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8348
8349
8350
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8360
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8364
8365
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8369
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8380
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8390
8391
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8399
8400
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8459
8460
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8471
8472
8473
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8495
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8499
8500
8501
8502
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8510
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<?xml version="1.0" encoding="UTF-8"?>
<questionnaire id="42241">
<title>Legal Requirements</title>
<investigator/>
<dataCollector/>
<questionnaireInfo>
<position>before</position>
<text>Welcome to the TIMBUS Project Legal Requirements Survey.</text>
<administration>self</administration>
</questionnaireInfo>
<section id="8">
<sectionInfo>
<position>title</position>
<text>IP Rights - Intro</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Do you want to preserve third party material/data?</text>
<response varName="42241X8X408">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>What kind of third party material do you want to preserve?</text>
<response varName="42241X8X409SQ001">
<fixed>
<category>
<label>Software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X8X409SQ002">
<fixed>
<category>
<label>Databases</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X8X409SQ003">
<fixed>
<category>
<label>Pictures</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X8X409SQ004">
<fixed>
<category>
<label>Text Documents</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="16">
<sectionInfo>
<position>title</position>
<text>IP Rights - Software</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note: The computer program is no longer protected by copyright, and you are not infringing Intellectual Property (IP) rights.��</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; The computer program is still copyright protected, so you will need to have a licence or other authorization, such as permission from the software developer, to use it. Otherwise you are infringing Intellectual Property (IP) rights. ��</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;p&gt;&#13;
Porting:��&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Certain acts necessary for Digital Preservation (DP) systems, including preservation, reproduction (porting) and alteration (migration) are prohibited without authorization. You are infringing Intellectual Property (IP) rights if there is no relevant legal exception.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;p&gt;&#13;
Porting:&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; Using the program after the licence has expired is an infringement of copyright. ��&lt;/p&gt;&#13;
&lt;p&gt; &#13;
&#13;
&lt;u&gt;Recommendation:&lt;/u&gt; Ensure there is a clause in the licence that allows you to continue to access digitally preserved information after the licence���s expiration date. &lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;p&gt;&#13;
Porting:&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; You are not infringing Intellectual Property (IP) rights. &lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;p&gt;&#13;
Migration:&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Certain acts necessary for Digital Preservation (DP) systems, including preservation, reproduction (porting) and alteration (migration), are prohibited without authorization. You are infringing Intellectual Property (IP) rights if there is no relevant legal exception.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Migration:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt;��Using the program after the licence has expired is an infringement of copyright. ��&lt;/p&gt;&#13;
&lt;p&gt; &#13;
&lt;u&gt;Recommendation:&lt;/u&gt;��Ensure there is a clause in the licence that allows you to continue to access digitally preserved information after the licence���s expiration date.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Migration:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; You are not infringing Intellectual Property (IP) rights.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Emulation:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Certain acts necessary for Digital Preservation (DP) systems, including preservation, reproduction (porting) and alteration (migration), are prohibited without authorization. You are infringing Intellectual Property (IP) rights if there is no relevant legal exception.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Emulation:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt;��Using the program after the licence has expired is an infringement of copyright. ��&lt;/p&gt; &#13;
&lt;p&gt;&#13;
&lt;u&gt;Recommendation:&lt;/u&gt;��Ensure there is a clause in the licence that allows you to continue to access digitally preserved information after the licence���s expiration date. &lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Emulation:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt;��You are not infringing Intellectual Property (IP) rights.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; Certain acts necessary for Digital Preservation (DP) systems, including preservation, reproduction (porting) and alteration (migration), are prohibited without authorization. You are infringing Intellectual Property (IP) rights if there is no relevant legal exception.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; There are several exceptions to the copyright holder���s exclusive rights in Art. 5 of the Computer Program Directive. Pursuant to Art. 5 (2), a licence cannot prohibit you from creating a backup copy if this is necessary to ensure continued use of the program. Furthermore, pursuant to Art. 5 (1), other rights of use are regarded as permitted if they are necessary for the use of the computer program by the lawful acquirer in accordance with its intended purpose.&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Germany: see �� 69d German Copyright Act (UrhG). According to Art. 5 (3) of the Computer Program Directive the lawful acquirer may perform all acts of loading, displaying, running, transmission or storage for the analysis of the program, if he is also otherwise entitled to undertake these restricted acts. Thus, Art. 5 (3) aims to avoid the indirect protection of generally unprotectable ideas and principles. As a result, the provision does not enlarge the circle of permissible acts in Art. 5, and allows no further reproductions or modifications of the program.��&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; Loading, running or error correction and the creation of a backup copy necessary to ensure continued use cannot be prohibited by contract. However, other rights of use are only allowed if there are no contradictory provisions in the contractual agreement.&#13;
&#13;
&lt;p&gt; &lt;u&gt;Note (optional):&lt;/u&gt; The term ���backup copy��� leaves it open as to whether you could produce several copies, but you would have to prove that a single backup copy was insufficient. (A backup copy is a copy of the sold or licensed program in its original version, but it is never be necessary for the use of a program). Having a backup copy is essential when the original copy is at risk of being damaged or destroyed, and a backup copy has not been delivered by the rightholder or a replacement cannot immediately be supplied.��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; Art. 5 of the Computer Program Directive is likely to apply. You are not infringing copyright.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; Art. 5 of the Computer Program Directive does not apply. You need to seek permission as otherwise you are infringing copyright.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; Art. 6 (1) of the Computer Program Directive constitutes an exception to the exclusive rights of the author of a program in relation to decompilation.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note (optional):&lt;/u&gt; You are permitted to decompile the whole program as long as it is not possible to identify the specific parts of the program necessary to achieve interoperability.&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; Reproduction of the source code or the translation of the object code into a source code is permitted. All acts of reproduction which are determined in Art. 4 lit. (a) of the Computer Program Directive , especially loading, displaying, running, transmitting or storing of the computer program, are allowed.&lt;/p&gt;&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&lt;u&gt;Note (optional):&lt;/u&gt; Art. 6 only legalizes such acts for the purpose of decompilation. Therefore, adapting, re-arranging or other changes are not permitted under this exception. It is also important to note that the decompiling exception of Art. 6 does not cover the decompiling of a program for the purpose of adapting it to meet your changed requirements.&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; Art. 6 (1) of the Computer Program Directive does not apply. You need to seek permission as otherwise you are infringing copyright.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; If the software is not protected by copyright, you can use it without a licence or any other form of authorization.��</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Is the software protected by copyright?</text>
<response varName="42241X16X798">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the software copyright protected?&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Computer programs in any form ��� e.g. software and those programs incorporated into hardware ��� are protected by law. In addition, every phase of the program���s development is protected, including any preparatory design work. The ideas and principles underlying the computer program are not protected, especially interfaces which guarantee interoperability between software and hardware. To be protected by copyright law, the program must be the author's own intellectual creation; there are no further requirements. Consequently, protection is granted for even a minimal degree of creativity (see Art. 1, Directive 2009/24/EC (Computer Program Directive)).&lt;/p&gt;&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Germany: See �� 69a German Copyright Act (UrhG)&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X16X799">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the term of copyright protection been expired?</text>
<response varName="42241X16X801">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>When does copyright protection expire?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;p&gt;&#13;
Has the term of copyright protection expired?&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Copyright expires 70 years after the author���s death.��&lt;/p&gt;</text>
<response varName="42241X16X802">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you have a licence?</text>
<response varName="42241X16X805">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does the licence contain a provision allowing porting?</text>
<response varName="42241X16X806">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Porting: &#13;
&lt;p&gt;Is the licence time-limited?&lt;/p&gt;</text>
<response varName="42241X16X810">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does the licence contain a provision in order to allow migration?</text>
<response varName="42241X16X808">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Migration: &#13;
&lt;p&gt; Is the licence time-limited?&lt;/p&gt;</text>
<response varName="42241X16X813">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does the licence contain a provision allowing emulation?</text>
<response varName="42241X16X809">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Emulation:&#13;
&lt;p&gt; Is the licence time-limited? &lt;/p&gt;</text>
<response varName="42241X16X816">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you a ���lawful acquirer���?</text>
<response varName="42241X16X821">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>What is a 'lawful acquirer'?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you a ���lawful acquirer���?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation: &lt;/u&gt;The term ���lawful acquirer��� intends to cover anyone who legitimately possesses a copy of a program with the right to use the program, e.g. the purchaser, an authorized program user (licensee) or any subsequent buyer who has obtained the copy without infringing copyright.&lt;/p&gt;</text>
<response varName="42241X16X822">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the action you want to carry out necessary for you to be able to use the software?</text>
<response varName="42241X16X823">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>What does 'necessary' mean?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the action you want to carry out necessary for you to be able to use the software?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; ��An action is necessary according to Art. 5 of the Computer Program Directive if your ability to use the program for its intended purpose remains impossible by any other reasonable actions.��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X16X824">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are there contradictory provisions in the licence contract?</text>
<response varName="42241X16X826">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is decompilation indispensable to create interoperability?</text>
<response varName="42241X16X831">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>What does 'indispensable' mean?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is decompilation indispensable to create interoperability?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Decompiling is only permitted if it is not possible to obtain the information necessary to achieve interoperability by any other means (���ultima ratio���). &lt;/p&gt;</text>
<response varName="42241X16X832">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is decompilation carried out by the licensee or by another person who has the right to use a copy of the program, or by a person authorized on their behalf to do so?</text>
<response varName="42241X16X833">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the necessary information been readily available previously?</text>
<response varName="42241X16X834">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is decompilation confined to the parts of the original program which are necessary for interoperability?</text>
<response varName="42241X16X835">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="4">
<sectionInfo>
<position>title</position>
<text>IP Rights - Database</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>When is a database copyright protected?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; A database is copyright protected by reason of way in which its content is selected or arranged. These acts constitute the ���author's intellectual creation���. Other criteria, such as quality or aesthetic value, are not taken into account.��&lt;/p&gt; &#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; If the database is laid out to be complete, which means to include all relevant information of a certain area, it is unlikely that it constitutes an intellectual creation in respect of selection, because in that case there is little room for creativity in the structure.&#13;
With regard to arrangement it is likely that electronic databases are not copyright protected, because the intellectual creation expressed in the arrangement is only found in the computer program.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Does the inclusion of copyright protected material affect copyright protection?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The incorporation of copyright protected content does not affect the existence of a copyright protection of the database.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Explanation :&lt;/u&gt; In Europe, copyright is protected for the lifetime of the rights holder and until the end of the 70th year after their death.�������������������������� &#13;
&lt;p&gt;&#13;
&lt;em&gt;&lt;u&gt;Note:&lt;/u&gt; Art. 10 Database Directive is not applicable for the copyright protection of a database.&lt;/em&gt;&lt;/p&gt; &#13;
&lt;p&gt; &#13;
What about non-EU countries? Is it the same worldwide?&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Countries outside the EU may have different copyright terms. &#13;
Examples:
&#13;
USA - 70 years after the death of the author
&#13;
China - 50 years after the death of the author
&#13;
Japan - 50 years after the death of the author&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Is copying or changing the database, or transferring it to a new storage device, allowed?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; In general you are not allowed to do any of these things; only the author has the exclusive right to do so. You must seek prior authorization to copy, change or transfer the database.����&lt;/p&gt;&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Art. 5 Database Directive contains an exhaustive list of restricted acts, and covers rights of reproduction, adaption, translation and arrangement of databases.&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Explanation :&lt;/u&gt; A lawful user is a person who uses the database with the consent of the right holder. Generally, this consent is given within the contract.&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; This provision establishes minimum rights for the lawful user which cannot be waived. Terms of contracts which run counter to this provision are null and void.
&lt;/p&gt;&#13;
&lt;p&gt; &lt;u&gt;Example:&lt;/u&gt; Browsing in the database is a normal use of it, and cannot be restricted by the right holder.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; You are not allowed to reproduce, alter or migrate the database. If you carry out any of these actions you are infringing Intellectual Property rights.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Who can grant permission?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt;The author or the rightholder can grant permission. According to the Database Directive, the author can only be an individual or a group of individuals. In addition, in some countries, a company or employer may, in law be the holder of the economic rights. For example, if an employee creates a database as part of their employment, it depends on the member state's implementation of the Directive as to whether the employer or the employee is the rightholder.������������������&lt;/p&gt; &#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; : In the UK and the Netherlands, the employer has the first ownership of any copyright in the database.
In Germany it is generally assumed that the employee is the rightholder, unless otherwise determined in their contract of employment.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Which rights must be granted in the contract with regard to long-term preservation?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The contract should explicitly grant the rights to reproduce, alter and migrate the database.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; Additionally, you should check if you comply with the provisions for sui generis protection.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; You comply with the provisions for copyright protection of databases. Nevertheless, you should check that you do not infringe the sui generis right.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Is copying or changing the database, or transferring it to a new storage device, allowed?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; You are not infringing the provisions for copyright protection of databases. Nevertheless, the answer depends on whether a sui generis right exists. Both systems may apply independently of each other.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>{if (db_q2_2_a_aa_substan.NAOK =='A2' , If substantial investment in changing the content of the database was made, the term of protection of 15 years starts again.' , '')}&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; The changes did not renew the term of protection, so it is out of copyright.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>{if(db_q2_2_a_aa_substan.NAOK == 'A1', 'If substantial investment in changing the content of the database was made, the term of protection of 15 years starts again. It runs from 1 January of the year following the date of completion, or, where the database is made available to the public, 15 years from 1 January of the year following the date when the database was first made available to the public.&lt;u&gt;Note:&lt;/u&gt; cf. Art. 10 (1) and (2) Database Directive.' , ' The investment of the database maker must be made in the obtaining, verification or presentation of independent and already existing data. The investment must be a relevant one. The mere acquisition of a database or the creation of the data itself have no relevance for the protection. The investment has to be made in the collection of the data or the listing.&lt;u&gt;Note:&lt;/u&gt; It has to be distinguished between creating and obtaining data. A reliable specification of the term "substantial" has not been given yet.' )}&#13;
&lt;p&gt;&#13;
&#13;
&lt;u&gt;Notice:&lt;/u&gt; The changes renewed the term of protection. The changed part is protected by the sui generis right.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Explanation:&lt;/u&gt; The definition in Art. 7 (2) (a) Database Directive mentions the temporary or permanent transfer of the content of the database to another medium. Within this definition a copy may be seen as an extraction.&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Reproduction, alteration and migration of a database must be regarded as the extraction of a substantial part.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; Extraction and re-use are the exclusive rights of the database maker. You need a licence to carry out these actions.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Who can grant permission?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The right holder of the sui generis right is the person who takes the initiative and risk of investing. Remember also that a juridical person can be the database maker.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; You do not infringe the sui generis right. The relevant digital preservation processes can be carried out.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; You are infringing the sui generis right of the right holder.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; With regard to insubstantial parts, only the lawful user is allowed to extract or re-use those parts of the database.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; You are infringing the sui generis right.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Are there any restrictions for the lawful user? &#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; A lawful user has the unlimited right to use the insubstantial part of the database as established in the contract. So, in general, extraction and re-use by a lawful user do not infringe the sui generis right. But if the act meets the criteria of a repeated and systematic extraction and/re-use, then it will fall within the provisions of the law.����������������������������������������������������������&lt;/p&gt; &#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; Repetition means that it happens more than once.&#13;
Systematic signifies that the extraction and /or re-use occur according to a plan.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; Making a copy of the database exceeds what a lawful user may do, because their rights pertain only to the insubstantial part of the content of the database.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>{if(db_q2_2_a_Changesin.NAOK == 'N', ' The term of protection has expired' , '')}&#13;
&lt;p&gt;&#13;
You do not infringe the sui generis right.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Is the database protected by copyright?</text>
<response varName="42241X4X231">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. When is a database copyright protected?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the database protected by copyright?</text>
<response varName="42241X4X234">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the term of copyright protection been expired?</text>
<response varName="42241X4X235">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know. How long does copyright protection last?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the term of copyright protection expired?</text>
<response varName="42241X4X237">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you have a licence which allows you to reproduce, alter or migrate the database?</text>
<response varName="42241X4X239">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>Art. 6 Database-Directive: Exception applicable?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you have a licence which allows you to reproduce, alter or migrate the database?</text>
<response varName="42241X4X241">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the database sui generis right protected?</text>
<response varName="42241X4X248">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. What is a sui generis right, and when is a database sui generis- protected?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has there been substantial investment in the database?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The sui generis right protects the substantial investment made in obtaining, verifying and preserving the content of a database. Note (for print-out): Recital 7 Database Directive (Directive 96/9/EG) mentions that every ���human, technical and financial resource��� used to achieve the database is an investment. More specifically, Recital 40 mentions the expenses of time, money and energy to show what is covered by the term ���investment���.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X4X249">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. Which requirements must be met in order to be considered a ���substantial investment���?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has there been substantial investment in the database?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The investment of the database maker must be in the obtaining, verification or presentation of independent and already existing data. The investment must be a relevant one. The mere acquisition of a database or the creation of the data itself has no relevance for the protection. The investment has to be made in the collection of the data or the listing.&lt;/p&gt; &#13;
&lt;p&gt; &lt;u&gt;Note:&lt;/u&gt; A distinction has to be made between creating and obtaining data. A reliable specification of the term ���substantial��� has not been given yet.&lt;/p&gt;</text>
<response varName="42241X4X250">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the term of copyright protection expired?</text>
<response varName="42241X4X252">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No. The database is still protected by the sui generis right</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. How long does copyright last?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the term of copyright protection expired?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The term of protection is 15 years. It runs from 1 January of the year following the database���s completion, or, where the database is made available to the public, 15 years from 1 January of the year following the date when the database was first made available to the public.������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 10 (1) and (2) Database Directive&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X4X253">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No. The database is still protected by the sui generis right</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Have there been any changes to the database���s content during this term of protection?</text>
<response varName="42241X4X254">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Was it a change that required a substantial investment?</text>
<response varName="42241X4X255">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. What is the definition of a ���substantial investment���?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Was it a change that required a substantial investment?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The database maker���s investment must be made in the obtaining, verification or presentation of independent and already existing data. The investment must be a relevant one. The mere acquisition of a database or the creation of the data itself has no relevance for the protection. The investment has to be made in the collection of the data or in the listing. &lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; It has to be distinguished between creating and obtaining data. A reliable specification of the term 'substantial' has not been given yet.&lt;/p&gt;</text>
<response varName="42241X4X256">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the renewed term of protection now expired?</text>
<response varName="42241X4X258">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you want to extract or re-use substantial parts of the database?</text>
<response varName="42241X4X259">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. What counts as a substantial part of the database?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you want to extract or re-use substantial parts of the database? &lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Substantiality is measured by qualitative and/or quantitative criteria. Quantity refers to the volume/amount of material which is extracted and/or re-used in comparison to the whole amount of independent material, which is stored in the database. Quality refers to the amount of investment which was necessary to obtain, verify and present the content extracted and/or re-used.��&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; The details of ���substantiality��� are left to the jurisprudence of the member states.&lt;/p&gt;</text>
<response varName="42241X4X260">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I still don���t know. Is making and storing a copy of the database an extraction or re-use of a substantial part?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you want to extract or re-use substantial parts of the database?</text>
<response varName="42241X4X262">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you have a licence which allows you to carry out reproduction, alteration or migration of the database?</text>
<response varName="42241X4X265">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you a lawful user?</text>
<response varName="42241X4X269">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. What���s the definition of a lawful user?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you a lawful user?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; A ���lawful user��� is a user to whom the database maker has made the database available and who uses the database with the agreement of the database maker.&lt;/p&gt;</text>
<response varName="42241X4X270">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I still don���t know. Is it necessary to have a direct contractual relationship with the database maker in order to be a lawful user?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you a lawful user?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; No. It is sufficient for you to have signed a licence with an authorized seller of the database.&lt;/p&gt;</text>
<response varName="42241X4X271">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="15">
<sectionInfo>
<position>title</position>
<text>IP Rights - Pictures</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; In addition to any copyright which may exist in a photograph or picture, you must also take into account rights belonging to anyone shown in the picture or photograph (���right to one's own image���). A weighing up of interests must take place, e.g. does the public have an interest in these pictures because they relate to contemporary history? As soon as a person shown in a picture is identifiable (at least to their own circle of acquaintances), personal rights are relevant.��</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; If the picture is not protected by copyright, you can use it without a licence or seeking permission in any other way.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Pictures not reaching a certain degree of originality can still be protected under national law. Directive 93/98/EEC grants member states the possibility of expanding the list of works which are protected (Art. 6).&#13;
&lt;p&gt;&#13;
{if (pic_q1_2_choosecount.NAOK == "A1" , 'The German Copyright Act (UrhG) distinguishes between photographic works and photographs. The former are protected pursuant to �� 2 I Nr. 5 UrhG, the latter pursuant to �� 72 UrhG.' , '')}&lt;/p&gt;&#13;
&lt;p&gt;&#13;
{if (pic_q1_2_choosecount.NAOK == "A2", 'The Austrian Copyright Act (��UrhG) distinguishes between photographic works and photographs. The former are protected pursuant to ���� 1, 3 ��UrhG, the latter pursuant to ���� 73 f. ��UrhG. Protection for photographic works expires 70 years after the author���s death (see �� 60 ��UrhG). Protection for photographs expires 50 years after the photograph has been made or has been published (see �� 74 VI ��UrhG).' , '')}&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>What is a photographic work?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Photographic works reflect the author's creativity and his or her visions. They must be the result of the author's own intellectual creation (see �� 2 II UrhG). Criteria used to assess the result are, e.g. the object, point of view, exposure, post-production processes etc. Furthermore, works enjoy the same protection as photographic works if they were created in a similar way, e.g. pictures made by a digital camera. Copyright is granted to the author of photographic or similar works.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>What is a photograph?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; : A photograph is defined as non-artistic, e.g. everyday amateur photographs or those photographs which are routinely manufactured. Rights are granted to the photographer (see �� 72 II UrhG).��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>How long is a photographic work protected?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Pursuant to �� 64 UrhG copyright expires 70 years after the author's death.&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice: &lt;/u&gt; Protection is granted even for a minimal degree of creativity (so called 'Kleine M��nze/ small coin').&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>How long is a photograph protected?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Pursuant to �� 72 III UrhG, the ancillary copyright expires 50 years after the photograph has been published.��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Note: If the picture is not protected by copyright, you can use it without a licence or seeking permission in any other way.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; The licence should explicitly state that you have the right of reproduction, migration and alteration as these actions are necessary for Digital Preservation systems. If the licence does not grant these rights, you are possibly infringing Intellectual Property (IP) rights.��</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; You are not allowed to store the pictures in a Digital Preservation system. If you do so without permission, you are infringing Intellectual Property (IP) rights.&#13;
&lt;p&gt;&#13;
Which rights must be granted in the licence with regard to Digital Preservation?&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; The licence should explicitly grant you the right of reproduction, migration and alteration because these actions are necessary for DP-systems.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Are the pictures protected by copyright?</text>
<response varName="42241X15X780">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the picture an individual work?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; A picture is an individual work if it is the result of the author's own intellectual creation. The work must reflect the author's personality in some way. Further criteria used to determine the degree of originality in the work are: object, point of view, exposure, post-production processes, etc.&lt;/p&gt;</text>
<response varName="42241X15X782">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;p&gt;&#13;
Please choose the country&lt;/p&gt;</text>
<response varName="42241X15X783">
<fixed>
<category>
<label>Germany</label>
<value>A1</value>
</category>
<category>
<label>Austria</label>
<value>A2</value>
</category>
<category>
<label>Other</label>
<value>-oth</value>
<contingentQuestion varName="42241X15X783other">
<text>Other</text>
<length>24</length>
</contingentQuestion>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the picture a photographic work or photograph?</text>
<response varName="42241X15X789">
<fixed>
<category>
<label>Photographic Work</label>
<value>A1</value>
</category>
<category>
<label>Photograph</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the photographic work still protected?</text>
<response varName="42241X15X787">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the photograph still protected?</text>
<response varName="42241X15X791">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the term of copyright protection expired?</text>
<response varName="42241X15X792">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the term of copyright protection expired?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt;��Pictures are protected until the end of the 70th year after the author's death.&lt;/p&gt;</text>
<response varName="42241X15X793">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you have a licence?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; The picture is still in copyright, and you will need permission from the copyright holder to proceed. Otherwise you are infringing Intellectual Property (IP) rights.&lt;/p&gt;</text>
<response varName="42241X15X795">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="9">
<sectionInfo>
<position>title</position>
<text>IP Rights - Text</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; The contract should explicitly grant you the rights of reproduction and alteration.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Notice:&lt;/u&gt; You are not allowed to reproduce, alter or publish the text document. If you carry out any of these actions you are infringing Intellectual Property rights.&lt;/p&gt;&#13;
&lt;p&gt;&#13;
Who can grant permission?&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The author/rights holder or someone authorized to act on their behalf can grant permission. According to national law an individual or an employer/company could hold the economic rights. If an employee created the text document, it depends on the member state's implementation of the Directive as to whether the employer or employee is the rights holder.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Which rights must be granted in the contract with regard to long-term preservation?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The contract should explicitly grant the rights of reproduction and alteration.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; The text document is not copyright protected, and you can use it without having a licence.</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Does the document only contain text or does it also include illustrations?</text>
<response varName="42241X9X461">
<fixed>
<category>
<label>It is a pure text document</label>
<value>A1</value>
</category>
<category>
<label>It contains technical/scientific illustrations</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are the text documents protected by copyright?</text>
<response varName="42241X9X462">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the text you are using an author's intellectual, individual creation?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; All kinds of literary work can be protected by copyright if they represent an ���author's intellectual creation���. If the text contains artistic means and belongs to the fine arts (e.g. literature, speeches), it is generally copyright protected. Technical instructions or academic reports, letters and forms are only copyright protected when their language, structure or stylistic means exceed the generally used and assumed form.&lt;/p&gt;</text>
<response varName="42241X9X463">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know. When is something considered to be an ���author's intellectual, individual creation���?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>What is the nature of the text document?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; It must be the result of some creative activity. Criteria such as quality or aesthetic value must not be taken into account. &#13;
The text must contain a minimal standard of originality in order to qualify for copyright. The use of stylistic means that distinguish the text from the average is sufficient. The level of originality for academic texts needs to be higher than for literary texts. The selection and arrangement of the content constitutes an intellectual creation.&lt;/p&gt;</text>
<response varName="42241X9X464">
<fixed>
<category>
<label>Text of the fine arts (e.g. article, literature)</label>
<value>A1</value>
</category>
<category>
<label>Text of an academic/technical nature</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the text you are using an author's intellectual, individual creation?</text>
<response varName="42241X9X465">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>How is the academic/technical information presented?</text>
<response varName="42241X9X466">
<fixed>
<category>
<label>A pure report of research results with technical terminology</label>
<value>A1</value>
</category>
<category>
<label>Evaluation of facts in the author���s own words (e.g. a degree of expertise is required)</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are the illustrations protected by copyright?</text>
<response varName="42241X9X467">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the author illustrate certain content by choosing the form, structure, colour etc. so that the illustration represents the ���author's intellectual, individual creation���?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation&lt;/u&gt;: Technical/scientific illustrations such as diagrams, plans, sketches and others are copyright protected by reason of their individual presentation.&lt;/p&gt;</text>
<response varName="42241X9X468">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the illustration an individual creation?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The content of the illustration does not affect copyright protection, but the illustration must be an intellectual, individual creation. Criteria such as quality or aesthetic value must not be taken into account.</text>
<text>The illustration must contain a minimum standard of originality in order to qualify for copyright. The use of stylistic means distinguishing the illustration from the average is sufficient.&lt;/p&gt;</text>
<response varName="42241X9X469">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Has the term of protection expired?&#13;
&lt;p&gt; &lt;u&gt;Explanation:&lt;/u&gt; In Europe, the duration of copyright protection lasts 70 years after the death of the right holder. &lt;/p&gt;</text>
<response varName="42241X9X470">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you have a licence?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; The document you are using is still protected under copyright law. In order to build or install a Digital Preservation system you need to copy and alter the document. For these actions permission is required.&lt;/p&gt;</text>
<response varName="42241X9X471">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="34">
<sectionInfo>
<position>title</position>
<text>Data Protection</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Select your country</text>
<response varName="42241X34X1505">
<fixed>
<category>
<label>Austria</label>
<value>A1</value>
</category>
<category>
<label>Germany</label>
<value>A2</value>
</category>
<category>
<label>Great Britain</label>
<value>A3</value>
</category>
<category>
<label>Ireland</label>
<value>A4</value>
</category>
<category>
<label>Portugal</label>
<value>A5</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you process personal data?</text>
<response varName="42241X34X1506">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; Personal data is any information relating to an identified or identifiable ���natural person��� ��� an individual person, as opposed to a legally created entity ��� (the 'data subject'). An identifiable person is one who can be identified, directly or indirectly, by reference to an identification number or by one or more factors specific to their physical, physiological, mental, economic, cultural or social identity.&#13;
&#13;
Do you process personal data?</text>
<response varName="42241X34X1510">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; If you do not preserve personal data, data protection laws do not have any impact on the preservation process. You do not need to consider the rules and regulations of data protection laws.</text>
<response varName="42241X34X1511">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is it possible to anonymize the data you want to preserve?&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; One way to circumvent the regulations of data privacy laws is to make the personal data you are preserving anonymous. This requires the deletion of any information related to a specific person. Anonymizing personal data may be a realistic option or just a theoretical possibility, depending on the re-use scenarios. If the preserving party is only interested in those parts of a data set which are non-personal, the irreversible anonymization of all personal information may be a possibility, thus circumventing the regulations of data protection laws. This option of making data anonymous may be of interest e.g., for research institutions. If, for instance, they only want to re-run a scientific workflow without knowing who ran or initiated the process, they could preserve this anonymized data without any problems. (For example, preserving the network activity of an intranet and replacing user information with randomized content). But if the intention of the preserver is to store all business data (including payroll information, information relevant to tax law, and other business process information) in one digital preservation store, an anonymization may not be possible, or at least not in their interest. If the basic concept of the Digital Preservation system is to preserve every relevant piece of information needed to exhume and rerun a process in the future, personal information such as contact information may be important for the exhumation process. Therefore, in this case, the option of anonymization will remain a theoretical option. &#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X34X1512">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; Data protection laws are not applicable.</text>
<response varName="42241X34X1513">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you process personal data?</text>
<response varName="42241X34X1514">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; Sensitive data is personal data revealing someone���s racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership; it also covers data concerning medical or sexual history.&#13;
&#13;
&lt;p&gt;&#13;
Do you process sensitive data?&lt;/p&gt;</text>
<response varName="42241X34X1515">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; The requirements for processing sensitive data are stricter than the requirements for processing ���regular��� personal data; that is why you must be aware of the regulations regarding sensitive data. The following questions must be considered every time you process personal data.&#13;
Which kind of data sources do you preserve?</text>
<subQuestion varName="42241X34X1516SQ001">
<text>Customer emails</text>
</subQuestion>
<subQuestion varName="42241X34X1516SQ002">
<text>Employee emails</text>
</subQuestion>
<subQuestion varName="42241X34X1516SQ003">
<text>Network information</text>
</subQuestion>
<response varName="42241X34X1516">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is it possible to identify an employee?</text>
<response varName="42241X34X1521">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; Provisions regarding employee data have to be considered.</text>
<response varName="42241X34X1522">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; Provisions regarding customer data have to be considered.</text>
<response varName="42241X34X1523">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Whose data do you preserve?</text>
<response varName="42241X34X1524SQ001">
<fixed>
<category>
<label>Customers��� data</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X34X1524SQ002">
<fixed>
<category>
<label>Employees���data</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Why do you want to preserve customer data? Please type in the field below.</text>
<response varName="42241X34X1527">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you sure that the preservation of this data is necessary to achieve that preservation purpose?&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; European data protection laws demand that all processing operations are strictly limited to the purpose originally notified to the data subject. This obligation results from the requirement to only collect data for specified, explicit and legitimate purposes, and that personal data must be appropriate, relevant and not excessive in relation to the purposes for which it is collected and/or further processed.</text>
<response varName="42241X34X1528">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>For what additional reason do you want to preserve customer data? Please type in the field below.</text>
<response varName="42241X34X1529">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did you inform your customer of the purpose for which you want to preserve their data?</text>
<response varName="42241X34X1530">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1531">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did you inform your customer of the purpose for which you want to preserve their data?</text>
<response varName="42241X34X1532">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1533">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1534">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did your customer give their consent for the preservation of their data for that purpose?</text>
<response varName="42241X34X1535">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1536">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did your customer give their consent for the preservation of their data for that purpose?</text>
<response varName="42241X34X1537">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Where do you want to store the preserved personal data?</text>
<response varName="42241X34X1538">
<fixed>
<category>
<label>The data will be stored where it originally was collected and not transferred to, e.g. another server.</label>
<value>A1</value>
</category>
<category>
<label>The data will be stored where it was originally collected in ���Country selected above���, but transferred to, e.g. another server in another country within the EU.</label>
<value>A2</value>
</category>
<category>
<label>The data will be stored where it was originally collected in ���Country selected above���, but transferred to, e.g. another server in another country outside the EU.</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1539">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did you inform your customer about the transfer of the data? &#13;
&lt;u&gt;Explanation:&lt;/u&gt; Transfer within the EU is generally not a problem. But the transfer is a kind of processing of personal data, and therefore it has to be covered either by the customer���s consent or by a processing exception regulation.</text>
<response varName="42241X34X1540">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt;There is a possible infringement of Data Protection laws; Check if you have to inform your customer.</text>
<response varName="42241X34X1541">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did your customer give their consent to the transfer of data, or is the transfer already covered by the customer���s consent for data to be preserved?</text>
<response varName="42241X34X1542">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1543">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the transfer of personal customer data necessary for the performance of a contract between your company and the customer, i.e. does it oblige you to transfer your customer���s personal data?&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; According to Art. 7 lit. b) Directive 95/46/EC processing of personal data is permitted if it is necessary for the performance of a contract between the processor and the data subject. However, this only applies if the data processing in the particular case is as well necessary for the fulfilment of the contract. &#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X34X1544">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1545">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Notice: There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1546">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the transfer necessary to comply with legal obligations?</text>
<response varName="42241X34X1547">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1548">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please type the corresponding legal obligation in the field below.</text>
<response varName="42241X34X1549">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the transfer necessary for the purposes of legitimate business interests?</text>
<response varName="42241X34X1550">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Notice: There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1551">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please type the legitimate interest in the field below.</text>
<response varName="42241X34X1552">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>To which country outside the EU will the data be transferred?</text>
<response varName="42241X34X1554">
<fixed>
<category>
<label>The data will be transferred to the USA</label>
<value>A1</value>
</category>
<category>
<label>The data will be transferred to another country outside the EU</label>
<value>A2</value>
</category>
<category>
<label>The data will be transferred within your company to a processor located in a country outside the EU and your company has established binding corporate rules</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did you inform your customer about the transfer?</text>
<response varName="42241X34X1555">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws; check whether you have to inform your customer.</text>
<response varName="42241X34X1556">
<fixed>
<category>
<label>Click to continue</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did your customer give their consent to transfer their data to the USA?</text>
<response varName="42241X34X1557">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1558">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the receiving company in the USA certified and compliant with the Safe Harbor Privacy Principles?</text>
<response varName="42241X34X1559">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice&lt;/u&gt;: There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1560">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1561">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the transfer of personal customer data necessary for the performance of a contract between your company and the customer, i.e. does it oblige you to transfer your customer���s personal data?&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; According to Art. 26 lit. b) Directive 95/46/EC, transferring personal data is permitted if it is necessary for the performance of a contract between the processor and the data subject. However, this only applies if the data processing in the particular case is as well necessary for the fulfilment of the contract. Transfer is also permitted if it is necessary for the performance of a contract between the data subject and the controller, or for the implementation of pre-contractual measures taken in response to the data subject's request. But this ���necessity���, given by the Directive, is interpreted very strictly by data protection authorities. Therefore, it is not readily possible to ���create��� a necessity by installing, e.g. an external central payroll mainframe in a third country outside the EU/EEA. In this case, many European data protection authorities will classify data transfer to this external mainframe (e.g. for billing purposes) as not necessary for the performance of the contract. They argue that although the transfer may be useful (e.g. because it is cheaper or easier to coordinate a worldwide centralized payroll organization), this kind of processing could also be done within the EU/EEA, and is therefore not necessary for the performance of the contract. The same classification applies to a transfer to the external data storage of a digital preservation system. This kind of processing (preservation/storing) could be done within the EU/EEA too. Therefore, the exception ���necessary for the performance of a contract��� may not provide a digital preservation system with a strong legal basis for international data transfer, unless the main purpose of the contract between the data transferor and the data subject is not the ���storage of personal data in a third country���.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X34X1562">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt;There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1563">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X34X1564">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the transfer necessary or legally required on the grounds of public interest, or for the establishment, exercise or defence of legal claims?</text>
<response varName="42241X34X1565">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1566">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please type the legal obligations in the field below.&#13;
&#13;
&lt;u&gt;Note&lt;/u&gt;: You comply with data protection laws.</text>
<response varName="42241X34X1567">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did you inform your customer about the transfer?</text>
<response varName="42241X34X1568">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws; check whether you have to inform your customer.</text>
<response varName="42241X34X1569">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did your customer give their consent to the transfer, or is the transfer already covered by the consent to preserve the data?</text>
<response varName="42241X34X1570">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1571">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the transfer of personal customer data necessary for the performance of a contract between your company and the customer, e.g. it obliges you to transfer your customer���s personal data?&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; According to Art. 26 lit. b) Directive 95/46/EC, processing of personal data is permitted if it is necessary for the performance of a contract between the processor and the data subject. However, this only applies if the data processing in the particular case is as well necessary for the fulfilment of the contract. The transfer is also permitted if it is necessary for the performance of a contract between the data subject and the controller, or the implementation of pre-contractual measures taken in response to the data subject's request. But this ���necessity���, given by the Directive, is interpreted very strictly by data protection authorities. Therefore, it is not readily possible to ���create��� a necessity by installing, e.g. an external central payroll mainframe in a third country outside the EU/EEA. In this case, many European data protection authorities will classify data transfer to this external mainframe (e.g. for billing purposes) as not necessary for the performance of the contract. They argue that although the transfer may be useful (e.g. because it is cheaper or easier to coordinate a worldwide centralized payroll organization), this kind of processing could also be done within the EU/EEA, so it is not necessary for the performance of the contract. The same classification applies to transfer to the external data storage of a digital preservation system. This kind of processing (preservation/storing) could also be done within the EU/EEA. Therefore, the exception ���necessary for the performance of a contract��� may not provide a digital preservation system with a strong legal basis for international data transfers, unless the main purpose of the contract between the data transferor and the data subject is not the ���storage of personal data in a third country���.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X34X1572">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1573">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1574">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the transfer necessary or legally required on grounds of public interest, or for the establishment, exercise or defence of legal claims?</text>
<response varName="42241X34X1575">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please type the legal obligations that apply.&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1576">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1577">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; By establishing such rules, a company imposes upon itself legally binding rules regarding the handling of personal data. As a result, adequate data protection levels can be ensured within the whole company (group). Therefore, the customer���s consent is not necessary. However, the rules have to meet all European and relevant national data protection requirements, and the data protection agencies have to officially approve these rules.&#13;
&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws, if you comply with the officially approved Binding Corporate Rules.</text>
<response varName="42241X34X1578">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the preservation of personal customer data necessary for the performance of a contract?&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; According to Art. 7 lit. b) Directive 95/46/EC, processing of personal data is permitted if it is necessary for the performance of a contract between the processor and the data subject. However, this applies only if the data processing in the particular case is as well necessary for the fulfilment of the contract.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X34X1579">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does this contract also cover long-term preservation?&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; If a company wants to use a long-term preservation system to store all business processes and services, including all information about their (former) customers, for the next 80 years, this storage of data is not covered by Art. 7 lit. b) of the Directive 95/46/EC, because in general a long-term preservation is not directly necessary for the performance of a contract between the processor and the data subject.&#13;
Is it necessary to preserve customer information even if the main contractual obligations are fulfilled?&#13;
&lt;u&gt;Explanation:&lt;/u&gt; In general, customer information has to be stored because it is necessary to fulfil, e.g. a sales contract. But long-term preservation of this data is not necessary, because you do not need this customer information after you fulfilled your contractual obligations. Because of the principle of data minimization, you should not preserve this data.&#13;
&#13;
��&#13;
&#13;
��&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X34X1580">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1581">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1582">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1583">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is there a contract between your company and the customer that obliges you to preserve your customer���s personal data?</text>
<response varName="42241X34X1584">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1585">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1586">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is preservation necessary to comply with a legal obligation?</text>
<response varName="42241X34X1587">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please type the legal obligation that applies in the field below.</text>
<response varName="42241X34X1588">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Notice: There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1589">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is preservation necessary for the purposes of legitimate business interests?</text>
<response varName="42241X34X1590">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1591">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1592">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Why do you want to preserve employee data? Please enter the information in the field below.</text>
<response varName="42241X34X1593">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you sure that the preservation of this data is necessary?&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; European data protection laws demand that all processing operations are strictly limited to the purpose originally notified to the data subject. This obligation results from the requirements to only collect data for specified, explicit and legitimate purposes and that the personal data must be appropriate, relevant and not excessive in relation to the purposes for which they are collected and/or further processed.</text>
<response varName="42241X34X1594">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please type another reason to preserve the data of your employee.</text>
<response varName="42241X34X1595">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did you inform your customer why you were preserving their data?</text>
<response varName="42241X34X1596">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1597">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did your employee give their consent to their data being preserved?</text>
<response varName="42241X34X1598">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1599">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you preserve employee data?</text>
<response varName="42241X34X1600">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws; check whether you have to inform your employee.</text>
<response varName="42241X34X1601">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did your employee give their consent to preserve their data?</text>
<response varName="42241X34X1602">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did your employee give consent in their employment contract?</text>
<response varName="42241X34X1603">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No, it was a separate agreement of consent.</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1604">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Was this consent still freely given?</text>
<response varName="42241X34X1605">
<fixed>
<category>
<label>Yes, the employee had the option not to consent to the processing of their data.</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1606">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did you inform your employee, that they can revoke their decision any time?</text>
<response varName="42241X34X1607">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1608">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1609">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the preservation of the personal employee data necessary for the performance of a contract?</text>
<response varName="42241X34X1610">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is there a contract between your company and the customer that obliges you to preserve your customer���s personal data?</text>
<response varName="42241X34X1611">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1612">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1613">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1614">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does this contract also cover long-term preservation?&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Is it necessary to preserve customer information even if the main contractual obligations are fulfilled? &lt;u&gt;Explanation:&lt;/u&gt; In general, customer information has to be stored because it is necessary to fulfil, e.g. a sales contract. But long-term preservation of this data is not necessary, because you do not need this customer information after you fulfilled your contractual obligations. Because of the principle of data minimization, you should not preserve this data.&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; If a company wants to use a long-term preservation system to store all business processes and services, including all information about their (former) customers, for the next 80 years, this storage of data is not covered by Art. 7 lit. b) of the Directive 95/46/EC, because in general a long-term preservation is not directly necessary for the performance of a contract between the processor and the data subject.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X34X1615">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1616">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1617">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is preservation necessary to comply with a legal obligation?</text>
<response varName="42241X34X1618">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please type the legal obligation that applies.</text>
<response varName="42241X34X1619">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1620">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is preservation necessary for the purposes of legitimate business interests?</text>
<response varName="42241X34X1621">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with data protection laws.</text>
<response varName="42241X34X1622">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a possible infringement of Data Protection laws.</text>
<response varName="42241X34X1623">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; The requirements for processing sensitive data are stricter than those for processing ���regular��� personal data. That is why the following questions have to be asked every time you process personal data.&#13;
&#13;
��&#13;
&#13;
Which kind of data sources do you preserve?</text>
<subQuestion varName="42241X34X1624SQ001">
<text>Customer emails</text>
</subQuestion>
<subQuestion varName="42241X34X1624SQ002">
<text>Employee emails</text>
</subQuestion>
<subQuestion varName="42241X34X1624SQ003">
<text>Network information</text>
</subQuestion>
<response varName="42241X34X1624">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is it possible to identify an employee using this network information?</text>
<response varName="42241X34X1628">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; Provisions regarding employee data have to be considered.</text>
<response varName="42241X34X1629">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; Provisions regarding employee data have to be considered.</text>
<response varName="42241X34X1630">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="17">
<sectionInfo>
<position>title</position>
<text>Contracting - Between DP User and External DP Provider</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; Provider can derivate this right from the client.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; Provider will need a license contract with the software producer or a sub-license contract with the DP customer (if permitted).</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Does an external provider execute the DP process?</text>
<response varName="42241X17X842">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the provider solely executing the rights of use without actually using the software?</text>
<response varName="42241X17X843">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the provider exploiting the software (at least partially for his own purpose)?</text>
<response varName="42241X17X844">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="18">
<sectionInfo>
<position>title</position>
<text>Contracting - Contracts Concerning Data Content of Preservation</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>business documents and records, procedure documentation, files of employees, management and legal documents</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; Proper confidentiality regulation in the contract necessary.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Attention:&lt;/u&gt; Aspects of copyright law must be taken into account.&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; For determining whether works are copyright protected or not and to identify the applicable law, you must decide on the type of the material (section IP Rights - Third party materials)&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Does an external provider execute the DP process?</text>
<response varName="42241X18X847">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are copyright protected works preserved?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Hint:&lt;/u&gt;�� For determining whether works are copyright protected or not and to identify the applicable law, you must decide on the type of the material (section IP Rights - Third party materials).&lt;/p&gt;</text>
<response varName="42241X18X848">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the DP user the copyright holder or does he have a contract with the copyright holder granting him the necessary rights?</text>
<response varName="42241X18X849">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="19">
<sectionInfo>
<position>title</position>
<text>Contracting - Framework Contracts for DP</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Recommendation:&lt;/u&gt; Entering into a Framework Contract for DP determining the outsourced execution. Content: Preamble, definitions, subject of the contract, contractual purpose, parties of the contract, obligations of the parties inclusive exact terms for payments, monitoring, tracking, reporting and auditing, rights of use, obligations of cooperation and change request management, warranty, liability, limitation of claims, force majeure, data security and data protection, confidentiality, non-competition clause, contract duration, termination, severability clauses, governing law and jurisdiction. Furthermore, ''service level agreements'' (SLA) describing the appointed services for the client in a transparent and highly detailed manner need to be incorporated in the contract.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; Development and Delivery Contracts have to be drawn in consideration of the general provisions in IT project contracts. The legal characteristics depend on the classification of contract types according to the applicable national law.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; Combined contracts: The most important topics in this case will be the warranty and liability of the provider.</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Does an external provider execute the DP process?</text>
<response varName="42241X19X852">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Have you determined the execution of digital archiving in a legal contract?</text>
<response varName="42241X19X853">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you want to execute DP internally?</text>
<response varName="42241X19X855">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you let another company develop a DP system?</text>
<response varName="42241X19X856">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does the DP provider develop the system customized for the needs of the particular DP user, execute the DP process and is he also responsible for the maintenance and support of the DP system?</text>
<response varName="42241X19X858">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="2">
<sectionInfo>
<position>title</position>
<text>Contracting - Escrow</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Please choose one of the following</text>
<response varName="42241X2X102">
<fixed>
<category>
<label>I am a software developer</label>
<value>A1</value>
</category>
<category>
<label>I am a software user</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Have you already contracted an Escrow Agreement?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Hint:&lt;/u&gt; Escrow Agreement is a contract between the software Developer, the software User and a neutral third party called the Escrow Agent. This contract establishes the obligation of the software developer to deposit the source code and the relevant material at the Escrow Agent. In case a triggering event occurs the Escrow Agents hands over the deposit material to the software user. &lt;/p&gt;</text>
<response varName="42241X2X103">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>What risks are covered by the existing Escrow Agreement? &#13;
&#13;
&lt;p&gt;&lt;u&gt;Hint for IP-Right Assignment: &lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt; An assignment of intellectual property rights means the transfer of those rights absolutely from the owner of this rights to another person or organization in return for payment. On the assignment of your rights to an assignee, the assignee becomes the proprietor of those rights and the ownership of the IPR would have transferred to the assignee as beneficial owner. The assignee will usually require an assignment with full title guarantee, which means no encumbrances on the IPR such as a charge. The assignee derives his rights from the transfer of the IPR and on the signing of the assignment can do all acts in relation to the IPR as though it belonged to him. An example of such acts includes the right to initiate proceedings for infringement of the IPR.&lt;/p&gt;</text>
<response varName="42241X2X104SQ001">
<fixed>
<category>
<label>Liquidation or extinction due to the lack of funds</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X104SQ002">
<fixed>
<category>
<label>No further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X104SQ003">
<fixed>
<category>
<label>Risk of Insolvency of the Licensor</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X104SQ004">
<fixed>
<category>
<label>Refusal or failure to fulfill the contractually established obligations</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X104SQ005">
<fixed>
<category>
<label>IP-Right assignment</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>In which country is the headquarter located?</text>
<response varName="42241X2X105">
<fixed>
<category>
<label>Austria</label>
<value>SQ001</value>
</category>
<category>
<label>Germany</label>
<value>SQ002</value>
</category>
<category>
<label>Great Britain</label>
<value>SQ003</value>
</category>
<category>
<label>Ireland</label>
<value>SQ004</value>
</category>
<category>
<label>Portugal</label>
<value>SQ005</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Attention:&lt;/u&gt; National Insolvency Law must be taken into account because it cannot be excluded by contracts.</text>
<response varName="42241X2X106">
<fixed>
<category>
<label>I have read and understood the above statement</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is an extension of the Escrow Agreement necessary?</text>
<response varName="42241X2X107">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>What other risks must be covered? &#13;
&lt;p&gt;&#13;
&lt;u&gt;Hint for the IP Rights Assignment:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
An assignment of intellectual property rights means the transfer of those&#13;
rights absolutely from the owner of this rights to another person or organisation in&#13;
return for payment. On the assignment of your rights to an assignee, the assignee&#13;
becomes the proprietor of those rights and the ownership of the IPR would have&#13;
transferred to the assignee as beneficial owner. The assignee will usually require an&#13;
assignment with full title guarantee, which means no encumbrances on the IPR such&#13;
as a charge. The assignee derives his rights from the transfer of the IPR and on the&#13;
signing of the assignment can do all acts in relation to the IPR as though it belonged&#13;
to him. An example of such acts includes the right to initiate proceedings for&#13;
infringement of the IPR.&lt;/p&gt;</text>
<response varName="42241X2X108SQ001">
<fixed>
<category>
<label>Liquidation or extinction due to the lack of funds</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X108SQ002">
<fixed>
<category>
<label>Risk of Insolvency of the Licensor</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X108SQ003">
<fixed>
<category>
<label>No further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X108SQ004">
<fixed>
<category>
<label>Refusal or failure to fulfil the contractually established obligation</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X108SQ005">
<fixed>
<category>
<label>IP rights assignment</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>{if (q1_isSWdeveloper.NAOK=='A1', 'Liquidation or extinction due to the lack of funds: I want to grant the following rights of use regarding the source code suspended until it is proofed that one of the triggering events established by the Escrow Agreement had occurred, to the software user', 'Liquidation or extinction due to the lack of funds: The following rights of use regarded the source code have to be granted to me as the software user, in a suspended form until it is proofed that one of the triggering events established by the Escrow Agreement had occurred')}&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention: &lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right to perform debugging: This is a right should always be granted to the user, because otherwise he is not able to correct errors. Otherwise an Escrow Agreement does not make sense&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development of the software: This right is necessary for the user if he has planned to use the software for a long time changes or improvements may be necessary and as the software developing company no longer exists, it is reasonable to grant the right to the user&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development and distribution of the software: If it is planned that the user should distribute the software than this rights should be granted&lt;/p&gt;</text>
<response varName="42241X2X109SQ001">
<fixed>
<category>
<label>The right to perform debugging</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X109SQ002">
<fixed>
<category>
<label>The right for the further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X109SQ003">
<fixed>
<category>
<label>The right for the further development and distribution of the software</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>In which country is the headquarter located?</text>
<response varName="42241X2X110">
<fixed>
<category>
<label>Austria</label>
<value>A1</value>
</category>
<category>
<label>Germany</label>
<value>A2</value>
</category>
<category>
<label>Great Britain</label>
<value>A3</value>
</category>
<category>
<label>Ireland</label>
<value>A4</value>
</category>
<category>
<label>Portugal</label>
<value>A5</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Attention:&lt;/u&gt; National Insolvency Law must be taken into account because it cannot be excluded by contracts.</text>
<response varName="42241X2X111">
<fixed>
<category>
<label>I have read and understood the above statement</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>{if (q1_isSWdeveloper.NAOK=='A1', 'Risk of Insolvency of the Licensor: I want to grant the following rights of use regarding the source code suspended until it is proofed that one of the triggering events established by the Escrow Agreement had occurred, to the software user', 'Risk of Insolvency of the Licensor: The following rights of use regarded the source code have to be granted to me as the software user, in a suspended form until it is proofed that one of the triggering events established by the Escrow Agreement had occurred')}&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right to perform debugging: This is a right should always be granted to the user, because otherwise he is not able to correct errors. Otherwise an Escrow Agreement does not make sense&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development of the software:�� This right is necessary for the user if he has planned to use the software for a long time changes or improvements may be necessary and as the software developing company no longer exists, it is reasonable to grant the right to the user&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development and distribution of the software: If it is planned that the user should distribute the software than this rights should be granted&lt;/p&gt;</text>
<response varName="42241X2X112SQ001">
<fixed>
<category>
<label>The right to perform debugging</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X112SQ002">
<fixed>
<category>
<label>The right for the further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X112SQ003">
<fixed>
<category>
<label>The right for the further development and distribution of the software</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>{if (q1_isSWdeveloper.NAOK=='A1', 'No further development of the software: I want to grant the following rights of use regarding the source code suspended until it is proofed that one of the triggering events established by the Escrow Agreement had occurred, to the software user', ' No further development of the software: The following rights of use regarded the source code have to be granted to me as the software user, in a suspended form until it is proofed that one of the triggering events established by the Escrow Agreement had occurred')}&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right to perform debugging: This is a right should always be granted to the user, because otherwise he is not able to correct errors. Otherwise an Escrow Agreement does not make sense&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development of the software:�� This right is necessary for the user if he has planned to use the software for a long time changes or improvements may be necessary and as the software developing company no longer exists, it is reasonable to grant the right to the user&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development and distribution of the software: If it is planned that the user should distribute the software than this rights should be granted&lt;/p&gt;</text>
<response varName="42241X2X113SQ001">
<fixed>
<category>
<label>The right to perform debugging</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X113SQ002">
<fixed>
<category>
<label>The right for the further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X113SQ003">
<fixed>
<category>
<label>The right for the further development and distribution of the software</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>{if (q1_isSWdeveloper.NAOK=='A1', 'Refusal or failure to fulfill the contractually established obligations: I want to grant the following rights of use regarding the source code suspended until it is proofed that one of the triggering events established by the Escrow Agreement had occurred, to the software user.', 'Refusal or failure to fulfill the contractually established obligations: The following rights of use regarded the source code have to be granted to me as the software user, in a suspended form until it is proofed that one of the triggering events established by the Escrow Agreement had occurred.')}&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right to perform debugging: This is a right should always be granted to the user, because otherwise he is not able to correct errors. Otherwise an Escrow Agreement does not make sense&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development of the software: This right is necessary for the user if he has planned to use the software for a long time changes or improvements may be necessary and as the software developing company no longer exists, it is reasonable to grant the right to the user&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development and distribution of the software: If it is planned that the user should distribute the software than this rights should be granted&lt;/p&gt;</text>
<response varName="42241X2X114SQ001">
<fixed>
<category>
<label>The right to perform debugging</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X114SQ002">
<fixed>
<category>
<label>The right for the further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X114SQ003">
<fixed>
<category>
<label>The right for the further development and distribution of the software</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>{if (q1_isSWdeveloper.NAOK=='A1', 'IP Rights Assignment: I want to grant the following rights of use regarding the source code suspended until it is proofed that one of the triggering events established by the Escrow Agreement had occurred, to the software user', 'IP Rights Assignment: The following rights of use regarded the source code have to be granted to me as the software user, in a suspended form until it is proofed that one of the triggering events established by the Escrow Agreement had occurred')}&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right to perform debugging: This is a right should always be granted to the user, because otherwise he is not able to correct errors. Otherwise an Escrow Agreement does not make sense&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development of the software: This right is necessary for the user if he has planned to use the software for a long time changes or improvements may be necessary and as the software developing company no longer exists, it is reasonable to grant the right to the user&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development and distribution of the software: If it is planned that the user should distribute the software than this rights should be granted&lt;/p&gt;</text>
<response varName="42241X2X115SQ001">
<fixed>
<category>
<label>The right to perform debugging</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X115SQ002">
<fixed>
<category>
<label>The right for the further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X115SQ003">
<fixed>
<category>
<label>The right for the further development and distribution of the software</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;p&gt;&#13;
If any of the following aspects provide you with considerable benefits, an Escrow Agreement would make sense. &lt;/p&gt;</text>
<response varName="42241X2X116SQ001">
<fixed>
<category>
<label>Confidence building measure regarding new clients</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X116SQ002">
<fixed>
<category>
<label>Independent verification of deposited materials which helps to improve it</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X116SQ003">
<fixed>
<category>
<label>Escrow as proof of the independency of the development and the existence of IP-Rights e.g. regarding competitors or employees, because with the deposing of the material at the Escrow Agent you can proof the state of the software at a certain moment which is documented by a neutral party</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X116SQ004">
<fixed>
<category>
<label>Escrow as safety instrument for patent claims in the USA due to the "1st-to-invent"-principle where because of the deposit of the material at the Escrow Agent you can proof when a certain state of a software were developed for the first time</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X116SQ005">
<fixed>
<category>
<label>Depending on the terms of the contract an Escrow Agreement may be a back up in case of disaster</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;p&gt;&#13;
You indicated that you have not contracted an Escrow Agreement yet. When does it make sense to sign an Escrow Agreement?&lt;/p&gt;</text>
<response varName="42241X2X132SQ001">
<fixed>
<category>
<label>The software used in the company supports critical processes e.g. the lack of availability or up-to-dateness of the system or data for a certain period of time may lead to considerable damages or productivity losses.</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X132SQ002">
<fixed>
<category>
<label>A short-tern substitution of the software require significant expenditures and binding of resources e.g. for the rechoice of a new software, the repaiment of license fees, eventually needed additional Hardware, cost of adaption of the new software to the existing software system, employee training costs...</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X132SQ003">
<fixed>
<category>
<label>The possibility of an insolvency of the software developer cannot be ruled out.</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X132SQ004">
<fixed>
<category>
<label>Potential unreliability exists regarding the contractually established maintenance, e.g. due to scarce capacity</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X132SQ005">
<fixed>
<category>
<label>There is a risk that the software developer stops the production of the product by the software developer because the software has long been on the marked or because of sale of the software developing company or the sale of the company section, which produces the utilized software.</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X132SQ006">
<fixed>
<category>
<label>There is the risk of cessation of the business activity of the software developer e.g. to avoid insolvency or because of the lack of economic viability of the business model.</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X132SQ007">
<fixed>
<category>
<label>There are contractual obligations to third parties and the fulfillment of these obligations depends on the availability and timeliness of the implemented software.</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you interested in contracting an Escrow Agreement?</text>
<response varName="42241X2X117">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>What risks should be covered? &#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Hint for IP-Right Assignment: &lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
An assignment of intellectual property rights means the transfer of those rights absolutely from the owner of this rights to another person or organization in return for payment. On the assignment of your rights to an assignee, the assignee becomes the proprietor of those rights and the ownership of the IPR would have transferred to the assignee as beneficial owner. The assignee will usually require an assignment with full title guarantee, which means no encumbrances on the IPR such as a charge. The assignee derives his rights from the transfer of the IPR and on the signing of the assignment can do all acts in relation to the IPR as though it belonged to him. An example of such acts includes the right to initiate proceedings for infringement of the IPR.&lt;/p&gt;</text>
<response varName="42241X2X118SQ001">
<fixed>
<category>
<label>Liquidation or extinction due to the lack of funds</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X118SQ002">
<fixed>
<category>
<label>No further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X118SQ003">
<fixed>
<category>
<label>Risk of Insolvency of the Licensor</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X118SQ004">
<fixed>
<category>
<label>Refusal or failure to fulfill the contractually established obligations</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X118SQ005">
<fixed>
<category>
<label>IP-Right assignment</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>{if (q1_isSWdeveloper.NAOK=='A1', 'Liquidation or extinction due to the lack of funds: I want to grant the following rights of use regarding the source code suspended until it is proofed that one of the triggering events established by the Escrow Agreement had occurred, to the software user', 'Liquidation or extinction due to the lack of funds: The following rights of use regarded the source code have to be granted to me as the software user, in a suspended form until it is proofed that one of the triggering events established by the Escrow Agreement had occurred')}&lt;/p&gt;&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention: &lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right to perform debugging: This is a right should always be granted to the user, because otherwise he is not able to correct errors. Otherwise an Escrow Agreement does not make sense&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development of the software: This right is necessary for the user if he has planned to use the software for a long time changes or improvements may be necessary and as the software developing company no longer exists, it is reasonable to grant the right to the user&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development and distribution of the software: If it is planned that the user should distribute the software than this rights should be granted&lt;/p&gt;</text>
<response varName="42241X2X119SQ001">
<fixed>
<category>
<label>The right to perform debugging</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X119SQ002">
<fixed>
<category>
<label>The right for the further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X119SQ003">
<fixed>
<category>
<label>The right for the further development and distribution of the software</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>In which country is the headquarter located?</text>
<response varName="42241X2X120">
<fixed>
<category>
<label>Austria</label>
<value>A1</value>
</category>
<category>
<label>Germany</label>
<value>A2</value>
</category>
<category>
<label>Great Britain</label>
<value>A3</value>
</category>
<category>
<label>Ireland</label>
<value>A4</value>
</category>
<category>
<label>Portugal</label>
<value>A5</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Attention:&lt;/u&gt; National Insolvency Law must be taken into account because it cannot be excluded by contracts.</text>
<response varName="42241X2X121">
<fixed>
<category>
<label>I have read and understood the above statement</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>{if (q1_isSWdeveloper.NAOK=='A1', 'Risk of Insolvency of the Licensor: I want to grant the following rights of use regarding the source code suspended until it is proofed that one of the triggering events established by the Escrow Agreement had occurred, to the software user', 'Risk of Insolvency of the Licensor: The following rights of use regarded the source code have to be granted to me as the software user, in a suspended form until it is proofed that one of the triggering events established by the Escrow Agreement had occurred')}&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right to perform debugging: This is a right should always be granted to the user, because otherwise he is not able to correct errors. Otherwise an Escrow Agreement does not make sense&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development of the software:�� This right is necessary for the user if he has planned to use the software for a long time changes or improvements may be necessary and as the software developing company no longer exists, it is reasonable to grant the right to the user&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development and distribution of the software: If it is planned that the user should distribute the software than this rights should be granted&lt;/p&gt;</text>
<response varName="42241X2X122SQ001">
<fixed>
<category>
<label>The right to perform debugging</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X122SQ002">
<fixed>
<category>
<label>The right for the further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X122SQ003">
<fixed>
<category>
<label>The right for the further development and distribution of the software</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>{if (q1_isSWdeveloper.NAOK=='A1', 'No further development of the software: I want to grant the following rights of use regarding the source code suspended until it is proofed that one of the triggering events established by the Escrow Agreement had occurred, to the software user', 'No further development of the software: The following rights of use regarded the source code have to be granted to me as the software user, in a suspended form until it is proofed that one of the triggering events established by the Escrow Agreement had occurred')}&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right to perform debugging: This is a right should always be granted to the user, because otherwise he is not able to correct errors. Otherwise an Escrow Agreement does not make sense&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development of the software:�� This right is necessary for the user if he has planned to use the software for a long time changes or improvements may be necessary and as the software developing company no longer exists, it is reasonable to grant the right to the user&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development and distribution of the software: If it is planned that the user should distribute the software than this rights should be granted&lt;/p&gt;</text>
<response varName="42241X2X123SQ001">
<fixed>
<category>
<label>The right to perform debugging</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X123SQ002">
<fixed>
<category>
<label>The right for the further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X123SQ003">
<fixed>
<category>
<label>The right for the further development and distribution of the software</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>{if (q1_isSWdeveloper.NAOK=='A1', 'Refusal or failure to fulfill the contractually established obligations: I want to grant the following rights of use regarding the source code suspended until it is proofed that one of the triggering events established by the Escrow Agreement had occurred, to the software user', 'Refusal or failure to fulfill the contractually established obligations: The following rights of use regarded the source code have to be granted to me as the software user, in a suspended form until it is proofed that one of the triggering events established by the Escrow Agreement had occurred')} &#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right to perform debugging: This is a right should always be granted to the user, because otherwise he is not able to correct errors. Otherwise an Escrow Agreement does not make sense&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development of the software: This right is necessary for the user if he has planned to use the software for a long time changes or improvements may be necessary and as the software developing company no longer exists, it is reasonable to grant the right to the user&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development and distribution of the software: If it is planned that the user should distribute the software than this rights should be granted&lt;/p&gt;</text>
<response varName="42241X2X124SQ001">
<fixed>
<category>
<label>The right to perform debugging</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X124SQ002">
<fixed>
<category>
<label>The right for the further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X124SQ003">
<fixed>
<category>
<label>The right for the further development and distribution of the software</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>{if (q1_isSWdeveloper.NAOK=='A1', 'IP Rights Assignment: I want to grant the following rights of use regarding the source code suspended until it is proofed that one of the triggering events established by the Escrow Agreement had occurred, to the software user', 'IP Rights Assignment: The following rights of use regarded the source code have to be granted to me as the software user, in a suspended form until it is proofed that one of the triggering events established by the Escrow Agreement had occurred')}&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right to perform debugging: This is a right should always be granted to the user, because otherwise he is not able to correct errors. Otherwise an Escrow Agreement does not make sense&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development of the software:��This right is necessary for the user if he has planned to use the software for a long time changes or improvements may be necessary and as the software developing company no longer exists, it is reasonable to grant the right to the user&lt;/p&gt;&#13;
&lt;p&gt;&#13;
The right for the further development and distribution of the software: if it is planned that the user should distribute the software than this rights should be granted.&lt;/p&gt;</text>
<response varName="42241X2X125SQ001">
<fixed>
<category>
<label>The right to perform debugging</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X125SQ002">
<fixed>
<category>
<label>The right for the further development of the software</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X125SQ003">
<fixed>
<category>
<label>The right for the further development and distribution of the software</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>I want the Escrow Agent to fulfill the following tasks: &#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
1: This is an essential task the Escrow Agent should fulfill&lt;/p&gt;&#13;
&lt;p&gt;&#13;
2: This is an essential task the Escrow Agent should fulfill if updates are planned&lt;/p&gt;&#13;
&lt;p&gt;&#13;
3: This is an essential task the Escrow Agent should fulfill to be sure the deposit material is useful&lt;/p&gt;&#13;
&lt;p&gt;&#13;
4: This is an essential task the Escrow Agent should fulfill&lt;/p&gt;&#13;
&lt;p&gt;&#13;
5: This task is important so that the other contracting party can fulfill the payment obligations and so avoid the�� termination of the Escrow Agreement&lt;/p&gt;&#13;
&lt;p&gt;&#13;
6: This is important to give the software developer the possibility to replay&lt;/p&gt;&#13;
&lt;p&gt;&#13;
7: This is an essential task the Escrow Agent should fulfill&lt;/p&gt;</text>
<response varName="42241X2X126SQ001">
<fixed>
<category>
<label>1: First receipt of the relevant material which is established in the Agreement and documentation of the received material</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X126SQ002">
<fixed>
<category>
<label>2: Receipt of the relevant material regarding the up-dates of the software and documentation of the received material</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X126SQ003">
<fixed>
<category>
<label>3: Verification of the deposit material</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X126SQ004">
<fixed>
<category>
<label>4: Storage of the deposit material</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X126SQ005">
<fixed>
<category>
<label>5: Notification obligation of the non-fulfilment of the payment obligation of the other contracting party</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X126SQ006">
<fixed>
<category>
<label>6: Notification obligation that the user has indicated the occurrence of a releasing event and has requested the handover of the deposit material because a triggering event has occurred</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X126SQ007">
<fixed>
<category>
<label>7: Handover of the deposit material to the software developer in case a triggering event occurs</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>What kind of verification do you want?&#13;
&#13;
&#13;
&lt;u&gt;Hint:&lt;/u&gt; Bespoken verification gives the client the possibility to establish in the contract all for him relevant verification steps and add some extra steps if necessary.</text>
<response varName="42241X2X127">
<fixed>
<category>
<label>Standard verification</label>
<value>A1</value>
</category>
<category>
<label>Full verification</label>
<value>A2</value>
</category>
<category>
<label>Bespoken Verification</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>The verification contains the following steps as established in the contract: &#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Attention:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
1: This is an essential task the Escrow Agent should fulfill&lt;/p&gt;&#13;
&lt;p&gt;&#13;
2: This task is important so that the other contracting party can fulfill the payment obligations and so avoid termination of the Escrow Agreement&lt;/p&gt;&#13;
&lt;p&gt;&#13;
3: This is an essential task the Escrow Agent should fulfill&lt;/p&gt;</text>
<response varName="42241X2X130SQ001">
<fixed>
<category>
<label>1: Storage of the deposit material</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X130SQ002">
<fixed>
<category>
<label>2: Notification obligation of the non-fulfillment of the payment obligation of the other contracting party</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X130SQ003">
<fixed>
<category>
<label>3: Handover of the deposit material to the software developer in case a triggering event occurs</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X130T">
<fixed>
<category>
<label>Other</label>
<value>1</value>
<contingentQuestion varName="42241X2X130other">
<text>Other</text>
<length>24</length>
</contingentQuestion>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;p&gt;&#13;
The verification contains the following steps:&lt;/p&gt;&#13;
&#13;
&#13;
Test of compellability to create an identical object code&#13;
&#13;
Identification of the material&#13;
&#13;
Examination of the formal accordance with the object of performance concerning the software and documentation including the necessary comments for the compilation and their tests&#13;
&#13;
Compilation eventually with the contribution of both contracting parties, documentation of the results and their examination, notification of the contracting parties and if it was successful&#13;
&#13;
Verification of the software and its executable&#13;
&#13;
Operability with corresponding reports</text>
<response varName="42241X2X129">
<fixed>
<category>
<label>I have read and understood the above statement</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>The verification contains the following steps:&#13;
&#13;
&#13;
&#13;
Identification of the material in comparison with the object of performance&#13;
&#13;
Virus free&#13;
&#13;
Completeness in comparison with the table of contents&#13;
&#13;
Ability to decompress compressed data&#13;
&#13;
Random samples of the documentation and their fitness for use</text>
<response varName="42241X2X128">
<fixed>
<category>
<label>I have read and understood the above statement</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;p&gt;&#13;
{if (q1_isSWdeveloper.NAOK=='A1', 'I want to grant the following rights to the Escrow Agent:' , 'The following rights must be granted to the Escrow Agent:')}&lt;/p&gt;</text>
<response varName="42241X2X131SQ001">
<fixed>
<category>
<label>Reproduction</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X131SQ002">
<fixed>
<category>
<label>Migration</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X2X131SQ003">
<fixed>
<category>
<label>Compiling</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="30">
<sectionInfo>
<position>title</position>
<text>Monitoring - Obligation to Preserve - Choose Your Sector</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>I'm working in the following branch:</text>
<response varName="42241X30X1259">
<fixed>
<category>
<label>Aviation</label>
<value>A1</value>
</category>
<category>
<label>Public Health</label>
<value>A2</value>
</category>
<category>
<label>None of the above</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="31">
<sectionInfo>
<position>title</position>
<text>Monitoring - Aviation</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Explanation:&lt;/u&gt; Regulation (EC) No. 216/2008 is the core piece of the EU aviation framework. It is completed by Regulation (EC) No. 1702/2003, No. 2042/2003.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with the provisions setting down digital preservation obligations for organizations that are responsible for the design, changes or repairs of products, parts and appliances.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Design:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; You might infringe EU legislation.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Design:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; You don't have to comply with the relevant provisions established in Regulation (EC) No. 1702/2003.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with the provisions setting out digital preservation obligations for organizations that are responsible for the manufacture of products, parts and appliances.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Manufacture:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; You might infringe EU legislation.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Manufacture:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; You don't have to comply with the relevant provisions established in Regulation (EC) No. 1702/2003.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with the provisions setting out digital preservation obligations for organizations that are responsible for maintenance of large aircraft or of aircraft used for commercial air transport, and components intended for fitment to these aircraft.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Maintenance:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; You might infringe EU legislation.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Maintenance:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; You don't have to comply with the relevant provisions established in Regulation (EC) No. 2042/2003.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with the provisions laying down digital preservation obligations for organizations that are involved in the continuing airworthiness of aircraft and components, including maintenance.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Continuing airworthiness:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; You might infringe EU legislation.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Explanation:&lt;/u&gt; In principle, the owner of an aircraft is responsible for its continuing airworthiness, but they may also contract the tasks associated with continuing airworthiness to an approved ���continued airworthiness management organization���(CAMO).��&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 3 of Directive (EC) No 2042/2003&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; You do not have to comply with the relevant provisions established in Regulation (EC) No. 2042/2003.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Are you a certified organization responsible for the design, change or repair of products, parts and appliances?</text>
<response varName="42241X31X1261">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
Responsible for design:&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; cf. Art. 3 Regulation (EC) No. 1702/2003&lt;/p&gt;</text>
<response varName="42241X31X1262">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. What kinds of obligation are there?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
You must:</text>
<text>- hold your documentation at the disposal of the EASA; and</text>
<text>- retain it in order to ensure the airworthiness and the compliance with the environmental protection requirements &lt;/p&gt;</text>
<response varName="42241X31X1263">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I am not sure. What kind of documentation has to be retained?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
Documentation to be retained includes all relevant design information, drawings and test reports, including inspection records for the product tested.&lt;/p&gt;&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 21.A.55 of Regulation (EC) No. 1702/2003</text>
<response varName="42241X31X1264">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you a certified organization responsible for the manufacture of products, parts and appliances?</text>
<response varName="42241X31X1268">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; cf Art. 4 of Regulation (EC) No. 1702/2003&lt;/p&gt;</text>
<response varName="42241X31X1269">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. What kinds of obligation exist?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
You must:</text>
<text>- hold your documentation at the disposal of the EASA</text>
<text>- retain it in order to ensure the airworthiness and the compliance with the environmental protection requirements</text>
<text>- record all details of work carried out</text>
<text>- establish an archiving system incorporating requirements imposed on your partners, suppliers and subcontractors, ensuring conservation of the data used to justify conformity of the products, parts or appliances��������������������������������������������������������������������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 21A.165 of Regulation (EC) No. 1702/2003&lt;/p&gt;</text>
<response varName="42241X31X1270">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I���m not sure. What documentation has to be retained?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; all relevant design information, drawings and test reports, including inspection records for the product tested.��������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 21.A.55 Regulation(EC) No 1702/2003&lt;/p&gt;</text>
<response varName="42241X31X1271">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you a certified organization involved in the maintenance of large aircraft or aircraft used for commercial air transport, and components intended for fitment to these aircraft?</text>
<response varName="42241X31X1275">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 4 of Regulation (EC) No. 2042/2003&lt;/p&gt;</text>
<response varName="42241X31X1276">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I���m not sure. What kinds of obligation exist?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; You must record all details of maintenance work carried out. As a minimum, you should retain records necessary to prove that all requirements have been met for the issuance of the certificate of release to service, including any subcontractor's release documents.����������������������������������������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 145.A.55 of Regulation (EC) No 2042/2003&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X31X1277">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I am not sure. What documentation has to be retained?</label>
<value>A3</value>
</category>
<category>
<label>I am not sure. In which way have the documents to be stored?</label>
<value>A4</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; records and any associated maintenance data must be stored for two years from the date the aircraft or component to which the work relates was released from your organization.��&lt;/p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 145.A.55 of Regulation (EC) No 2042/2003&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X31X1278">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I���m not sure. How must the documents be stored?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; They must be stored securely with regard to fire, flood and theft.</text>
<text>Computer backup discs, tapes etc. shall be stored in a different location from that where the working discs, tapes etc. are stored, in an environment that ensures they remain in good condition.&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 145.A.55 of Regulation (EC) No 2042/2003&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X31X1279">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; They They must be stored securely with regard to fire, flood and theft.</text>
<text>Computer backup discs, tapes etc. shall be stored in a different location from that where the working discs, tapes etc. are stored, in an environment that ensures they remain in good condition.&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 145.A.55 of Regulation (EC) No 2042/2003&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X31X1280">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I���m not sure. How long must the data be retained for?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; A copy of all detailed maintenance records and any associated maintenance data must be stored for two years from the date the aircraft or component to which the work relates was released from your organization.��&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 145.A.55 of Regulation (EC) No 2042/2003&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X31X1281">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you a certified organization involved in the continuing airworthiness of aircraft and components, including maintenance?</text>
<response varName="42241X31X1285">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; In principle, the owner of an aircraft is responsible for its continuing airworthiness, but they may also contract the tasks associated with continuing airworthiness to an approved ���continued airworthiness management organization���(CAMO).��&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 3 Regulation (EC) No 2042/2003&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X31X1286">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. What kinds of obligation are there?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
You must:</text>
<text>- archive all technical records,</text>
<text>- keep various certificates and associated documents&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. M.A.714 of Regulation (EC) No 2042/2003&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X31X1287">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I���m not sure. What kind of records, certificates and documents have to be kept?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:315:0001:0165:EN:PDFDo you comply with the document retention obligations established in the Regulation?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt;&lt;/p&gt;&#13;
&lt;p&gt;&#13;
Under this obligation you must, for example:</text>
<text>- retain maintenance data</text>
<text>- ensure that all applicable maintenance data is current and readily available for use when required</text>
<text>- list your airworthiness review staff (together with their airworthiness review authorization reference) in the Continuing Airworthiness Management Exposition</text>
<text>- maintain a record of all airworthiness review staff, which shall include details of any appropriate qualification held together with a summary of relevant continuing airworthiness management experience and training, and a copy of the authorization</text>
<text>- manage and archive all continuing airworthiness records and/or operator's technical log.����&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; ccf M.A.401; M.A. 707; M.A.709; M.A.305; M.A.306 Regulation (EC) No 2042/2003&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X31X1288">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="32">
<sectionInfo>
<position>title</position>
<text>Monitoring - Public Health</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Why is record-keeping useful with regard to medical liability?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; In general, there are no special record-keeping obligations for European physicians and hospitals. Still, record-keeping can help if you have to answer claims for medical liability.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>What does ���malpractice��� mean?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; In some cases, the physician���s liability may ensue from substandard medical care (malpractice). Physicians are held to a very high standard of care.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>What does ���information error��� mean?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; In order for the patient to give their valid consent to medical treatment, they have to be given information regarding the risks and any alternative treatments. Incorrect or incomplete information can lead to an ���information error���.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>How long do records have to be stored for?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Traceability has to be ensured by the member states for at least 30 years.��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 14 Directive 2002/98/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>How long do records have to be stored for?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Traceability has to be ensured by member states for at least 30 years. The records of the information required in Annexes II and IV and under Article 29(b), (c) and (d) of Directive 2002/98/EC have to be kept for a minimum of 15 years.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 13 Directive 2002/98/EC; cf. Art. 4 Directive 2005/61/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>How long do records have to be stored for?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Traceability has to be ensured by member states for at least 30 years. The records of the information required in Annexes II and IV and under Article 29(b), (c) and (d) of Directive 2002/98/EC have to be kept for a minimum of 15 years.����&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 13 Directive 2002/98/EC; cf. Art. 4 Directive 2005/61/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>How long do records have to be stored for?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Data required for full traceability must be kept for a minimum of 30 years after clinical use. The records are required by Annex VI of Directive 2006/86/EC have to be retained for at least 30 years.������������������������������������������������������&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 8 Directive 2004/23/EC; cf. Art. 9 Directive 2006/86/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Are there any regulations covering storage specifications?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Yes. The sponsor, or marketing authorization holder, if different, shall be responsible for ensuring that records are retained as required for marketing authorization in accordance with Annex I to Directive 2001/83/EC, if required for a subsequent marketing authorization. In addition, data stored by electronic storage systems must be made readily available in legible form and be provided to the competent authorities at their request. Electronically stored data shall be protected by methods such as duplication or back-up and transfer onto another storage system, against loss or damage of data, and audit trails shall be maintained.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 9 Directive 2003/94/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>How long must the documentation be retained for?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; For a medicinal product, the batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates or at least five years after the certification referred to in Article 51(3) of Directive 2001/83/EC, whichever is the longer period.
&#13;
For an investigational medicinal product, the batch documentation shall be retained for at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used.��������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 9 Directive 2003/94/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>&lt;u&gt;Note:&lt;/u&gt; You don't have to consider the special rules.</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Are there any regulations covering storage specifications?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Data stored by electronic storage systems must be made readily available in legible form, and shall be protected against loss or damage of data by methods such as duplication or back-up and transfer onto another storage system.��������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 9 Directive 91/412/EEC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>How long must the documentation be retained for?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The records required in Art. 50 lit. g) Directive 2001/82/EC shall be available for inspection by the competent authorities for a period of at least three years.
&#13;
The batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates or at least five years after the certification referred to in Art. 55 (3) Directive 2001/82/EC, whichever is the longer period.������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art.�� 50 lit. g) Directive 2001/82/EC
&#13;
cf. Art. 9 Directive 91/412/EEC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Please choose one of the following fields:</text>
<response varName="42241X32X1292SQ001">
<fixed>
<category>
<label>A) Medical liability</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X32X1292SQ002">
<fixed>
<category>
<label>B) Medical data</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X32X1292SQ003">
<fixed>
<category>
<label>C) Medicinal products</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you know the two most important medical liability cases?</text>
<response varName="42241X32X1294">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; The two most important medical liability cases are 'information error' and 'malpractice'.</text>
<response varName="42241X32X1298">
<fixed>
<category>
<label>I understood the above statement</label>
<value>A1</value>
</category>
<category>
<label>What does 'information error' mean?</label>
<value>A2</value>
</category>
<category>
<label>What does 'malpractise' mean?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>What does ���information error��� mean?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; In order for the patient to give their valid consent to medical treatment, they have to be given information regarding the risks and any alternative treatments. Incorrect or incomplete information can lead to an ���information error���.&lt;/p&gt;</text>
<response varName="42241X32X1299">
<fixed>
<category>
<label>I understand the above statement.</label>
<value>A1</value>
</category>
<category>
<label>What does 'malpractise' mean?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>What does ���malpractice��� mean?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; In some cases, the physician���s liability may ensue from substandard medical care (malpractice). Physicians are held to a very high standard of care.&lt;/p&gt;</text>
<response varName="42241X32X1301">
<fixed>
<category>
<label>I understand the above statement.</label>
<value>A1</value>
</category>
<category>
<label>What does 'information error' mean?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you keep records of information given to patients, and their consent, as well as documentation of treatment carried out?</text>
<response varName="42241X32X1303">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Result:&lt;/u&gt; Record-keeping may help to avoid liability by providing exonerating evidence. However, be aware that data protection laws may apply.</text>
<response varName="42241X32X1304">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; The burden of proof for correct and complete information lies with the physician. With regard to malpractice, the outcome depends on the country you are working in. In some countries, such as Austria, there is so-called prima-facie evidence. Firstly the patient has to prove the damage (bodily harm). If they can do so, it is sufficient for them to prove that malpractice has increased significantly the probability of bodily harm being caused. If certain preconditions are met, the burden of proving a causal relationship between fault and damage may even be shifted towards the physician. Record-keeping may then help by providing exonerating evidence.</text>
<response varName="42241X32X1305">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data system comply with the necessary requirements?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; National regulations as well as the law of the EU can constitute record-keeping obligations for medical data. While national regulations can be set unconditional (in accordance to the constitution), the EU is only empowered to arise obligations in special fields. Some of those can be found in Art. 168 (4) TFEU, which empowers the EU to adopt harmonization measures setting high standards of quality and safety for organs, substances of human origins and medicinal products and devices.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1306">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I dont't know. What requirements have to be minded?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>There are different levels of storage specification and there may be obligations arising from EU law. In addition, national regulations and jurisprudence have to be considered. &#13;
&lt;p&gt;&#13;
Please choose one of the following:&lt;/p&gt;</text>
<response varName="42241X32X1307">
<fixed>
<category>
<label>Storage specifications set by the EU</label>
<value>A1</value>
</category>
<category>
<label>National regulations/jurisprudence</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does the medical data you hold concern blood and blood components?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Regulations set by European Directives have to be converted into law in individual member states.&lt;/p&gt;</text>
<response varName="42241X32X1308">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you run a hospital blood bank?</text>
<response varName="42241X32X1309">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data system comply with the necessary requirements?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Hospital blood bank ���shall mean a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital-based transfusion activities���.������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 3 lit f. Directive 2002/98/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1310">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I do not know. What requirements have to be minded?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt;��You are obliged to keep a record containing various data on traceability of blood or blood components. Furthermore, you must maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms.&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 4 Directive 2005/61/EC; cf. Art. 12 Directive 2002/98/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1311">
<fixed>
<category>
<label>I understand the above statement.</label>
<value>A1</value>
</category>
<category>
<label>For how long have the records to be stored?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data system comply with the necessary requirements?</text>
<response varName="42241X32X1313">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Hospital Blood Bank:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Regulations set by the EU contain the minimum requirements for the member states. National rules corresponding to this Directive have to be complied with. Be aware that there are special data protection obligations: all data, including genetic information, collated within the scope of Directive 2002/98/EC to which third parties have access must be rendered anonymous so that the donor is no longer identifiable.��������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 24 Directive 2002/98/EC������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
You must ensure:</text>
<text>that data security measures are in place as well as safeguards against unauthorized data additions, deletions or modifications to donor files or deferral records, and transfer of information;</text>
<text>that procedures are in place to resolve data discrepancies /&gt; that no unauthorized disclosure of such information occurs, whilst guaranteeing the traceability of donations.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1314">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Hospital Blood Bank:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Your medical data system does not meet the legal requirements. This may lead to liability or penalties regulated by the state.&lt;/p&gt;</text>
<response varName="42241X32X1315">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you run a blood establishment?</text>
<response varName="42241X32X1316">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data system comply with the necessary requirements?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Blood establishments are all those institutions handling human blood or blood components.��&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 3 lit e. Directive 2002/98/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1317">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I do not know. What requirements have to be minded?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; You are obliged to keep a record containing various data on traceability provided for in Art. 4 of Directive 2005/61/EC. Furthermore, you must maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms. Additionally, you must maintain records of the information required in Annexes II and IV and under Article 29(b), (c) and (d) of Directive 2002/98/EC.����&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 4 Directive 2005/61/EC; cf. Art. 12 Directive 2002/98/EC; cf. Art. 13 Directive 2002/98/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1318">
<fixed>
<category>
<label>I understand the above statement</label>
<value>A1</value>
</category>
<category>
<label>For how long do the records have to be stored?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data system comply with the necessary requirements?</text>
<response varName="42241X32X1320">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Blood Establishment:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Regulations set by the EU for the member states contain usually the minimum of legal requirements. The corresponding national rules to this Directive have to be complied with. Be aware that there are special data protection obligations: all data, including genetic information, collated within the scope of��Directive 2002/98/EC to which third parties have access must be rendered anonymous so that the donor is no longer identifiable.��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 24 Directive 2002/98/EC�� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� ����&lt;/p&gt;&#13;
&lt;p&gt;&#13;
You must ensure: that data security measures are in place as well as safeguards against unauthorized data additions, deletions or modifications to donor files or deferral records, and transfer of information;</text>
<text>that procedures are in place to resolve data discrepancies;</text>
<text>that no unauthorized disclosure of such information occurs, whilst guaranteeing the traceability of donations.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1321">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Blood Establishment:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Your medical data system does not meet the legal requirements. This may lead to liability or penalties regulated by the states.&lt;/p&gt;</text>
<response varName="42241X32X1322">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you run a blood facility?</text>
<response varName="42241X32X1323">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data system comply with the necessary requirements?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; A facility can be any institution to which blood or blood components may be delivered.������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 1 lit f. Directive 2005/61/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1324">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I do not know. What requirements have to be minded?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt;�� You are obliged to keep a record containing various data on traceability of blood or blood components. Furthermore, you must maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms.��&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 4 Directive 2005/61/EC; cf. Art. 12 Directive 2002/98/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1325">
<fixed>
<category>
<label>I understand the above statement.</label>
<value>A1</value>
</category>
<category>
<label>For how long do the records have to be stored?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data system comply with the necessary requirements?</text>
<response varName="42241X32X1327">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Blood Facility:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Regulations set by the EU for the member states contain usually the minimum of legal requirements. The corresponding national rules to this Directive have to be complied with. Be aware that there are special data protection obligations: all data, including genetic information, collated within the scope of Directive 2002/98/EC to which third parties have access must be rendered anonymous so that the donor is no longer identifiable.��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 24 Directive 2002/98/EC&lt;/p&gt;&#13;
&lt;p&gt;&#13;
You must ensure:</text>
<text>that data security measures are in place as well as safeguards against unauthorized data additions, deletions or modifications to donor files or deferral records, and transfer of information;</text>
<text>that procedures are in place to resolve data discrepancies;</text>
<text>that no unauthorized disclosure of such information occurs, whilst guaranteeing the traceability of donations.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1328">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Blood Facility:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Your medical data system does not meet the legal requirements. This may lead to liability or penalties regulated by the states.&lt;/p&gt;</text>
<response varName="42241X32X1329">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does the medical data concern human tissues and cells?</text>
<response varName="42241X32X1330">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data system comply with the necessary requirements?</text>
<response varName="42241X32X1331">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. What requirements have to be complied with?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt;��You are obliged to keep a record containing various data on traceability provided for in Art. 4 of Directive 2005/61/EC. Furthermore, you must maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms. Additionally, you must maintain records of the information required in Annexes II and IV and under Article 29(b), (c) and (d) of Directive 2002/98/EC.��&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 8 Directive 2004/23/EC; cf. Art. 10 Directive 2004/23/EC; cf. Art. 9 Directive 2006/86/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1332">
<fixed>
<category>
<label>I understand the above statement.</label>
<value>A1</value>
</category>
<category>
<label>For how long have the records to be stored?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data system comply with the necessary requirements?</text>
<response varName="42241X32X1334">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Human Tissues:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Regulations set by the EU for the member states contain usually the minimum of legal requirements. The corresponding national rules to this Directive have to be complied with.</text>
<text>Be aware that there are special data protection obligations: all data, including genetic information, collated within the scope of Directive 2004/23/EC to which third parties have access must be rendered anonymous so that the donor is no longer identifiable.</text>
<text>Be aware that national regulations may lay down additional obligations, so please check your national governing law.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 14 Directive 2004/23/EC</text>
<text>It has to be ensured that:</text>
<text>You must ensure that: data security measures are in place, as well as safeguards against any unauthorized data additions, deletions or modifications to donor files or deferral records, and transfer of information; procedures are in place to resolve data discrepancies; and no unauthorized disclosure of information occurs, whilst guaranteeing the traceability of donations.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1336">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Human Tissues:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Your medical data system does not meet the legal requirements. This may lead to liability or penalties regulated by the state. Be aware that national regulations may lay down additional obligations so please check your national governing law.&lt;/p&gt;</text>
<response varName="42241X32X1335">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Be aware that national regulations may lay down additional obligations, so please check your national governing law.</text>
<response varName="42241X32X1337">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; Storage specifications by EU-law constitute only a minimum level. National realization of the specific Directives as well as possible additional sector specific obligations have to be minded.&#13;
Please choose your country:&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1338">
<fixed>
<category>
<label>Germany</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you a doctor?</text>
<response varName="42241X32X1643">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you preserve data on findings, treatments and measures taken for at least 10 years after the end of the treatment and in an appropriate way?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. �� 57 (3) Bundesmantelvertrag ��rzte, �� 13 (10) Bundesmantelvertrag ��rzte/Ersatzkassen and the respective Medical Association's professional codes of conduct (Berufsordnung) in the German L��nder (cf. �� 10 Musterberufsordnung der Bundes��rztekammer)&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1644">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; Then you comply with the codes of conduct of the German Medical Associations. But be aware that there may be specific regulations requiring longer retention periods.</text>
<response varName="42241X32X1645">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of obligations.</text>
<response varName="42241X32X1646">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you use blood products or genetically engineered plasma proteins for your treatments?</text>
<response varName="42241X32X1647">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; Pursuant to �� 14 (1), (3) Transfusionsgesetz, doctors must document every use of blood products or genetically engineered plasma proteins to treat haemostatic disorders for at least 15 years; some specific information (enumerated in �� 14 (2) Transfusionsgesetz) for up to 30 years. However, if the data is no longer necessary for purposes of the Transfusionsgesetz, for the medical treatment of the donor or purposes of risk management pursuant to the Arzneimittelgesetz, it must be deleted (note that these are exceptional cases, e.g. if the patient has died and the data is of no use for any of the purposes mentioned above). Data that has been stored for more than 30 years has to be made anonymous.&#13;
Does your data system comply with these requirements?&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1648">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligations.</text>
<response varName="42241X32X1649">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1650">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you work as a ���Durchgangsarzt���(D-Arzt, an accident insurance consultant doctor) with approval from the Employers��� Liability Insurance Associations in the field of trauma surgery?</text>
<response varName="42241X32X1651">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you preserve all documents about the ���Durchgangsarzt��� process, including X-ray images, for at least 15 years?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. part C.4 of the Richtlinien f��r die Bestellung von Durchgangs��rzten.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1652">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligations.</text>
<response varName="42241X32X1653">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of obligations.</text>
<response varName="42241X32X1654">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your data concern genetic examinations, testings, screenings or analysis?</text>
<response varName="42241X32X1655">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do your preserve the results of such genetic examinations, testing, screening and analysis for 10 years (if the subject has not expressed their wish for them to be deleted immediately)?</text>
<response varName="42241X32X1656">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you delete the data after 10 years?</text>
<response varName="42241X32X1657">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; There is a general obligation to delete this data after ten years. But if there are indications that deletion may affect the legitimate interests of the subject, or the subject has requested in writing a longer preservation period, the access to the data has only to be blocked rather than the data deleted. For further details see �� 12 Gendiagnostikgesetz.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1658">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Deleting these results without the explicit and written consent of the patient may infringe legal obligations pursuant to �� 12 Gendiagnostikgesetz.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1659">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you carry out cytological examinations?</text>
<response varName="42241X32X1660">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you store documentation on the findings from cytological examinations and preparations for ten years?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. �� 8 (6) Krebsfr��herkennungs-Richtlinie des Gemeinsamen Bundesausschusses</text>
<response varName="42241X32X1661">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligation.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1662">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Notice: Infringement of obligations.</text>
<response varName="42241X32X1663">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you comply with the obligations to preserve data on medical laboratory examinations?&#13;
&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The ���Richtlinie der Bundes��rztekammer zur Qualit��tssicherung laboratoriumsmedizinischer Untersuchungen��� (Guidelines of the German Medical Association on Quality Assurance for Laboratory Medical Examinations) lay down various obligations to preserve information from medical laboratory examinations:&#13;
- data on equipment used that might have relevance for the quality of the examinations, such as name of the device, producer, date of bringing it into service, etc., have to be preserved for two 2 after the end of use,&#13;
cf. no. A-5.4.3 - Data on errors during the examination and the countermeasures taken have to be preserved for 2 years, cf. no. A-7.5 - Documentation of the results of internal quality assurance have to be preserved for 5 years, cf. no. B1-2.1.7, B2-2.1.3, B3-2.1.4, B4-2.1.3, B5-2.1.4 - Certification of participation in external quality assurance measures (���Ringversuche���) must be preserved for at least 5 years, cf. no B1-2.2, B3-2.2, B5 2.2</text>
<response varName="42241X32X1664">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of obligations.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1665">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you preserve prescriptions for narcotic drugs and related documentation for 3 years after the last record?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. ���� 8 (5), 10 (4), 13 (3) Bet��ubungsmittel-Verschreibungsverordnung&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1666">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligations.</text>
<response varName="42241X32X1667">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1668">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you preserve letters of referral for at least one year?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. �� 7 (2) Appendix 4 to Bundesmantelvertrag ��rzte/Ersatzkassen&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1669">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligations.</text>
<response varName="42241X32X1670">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of obligations.</text>
<response varName="42241X32X1671">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you preserve your copies of issued certificates of incapacity for work for at least one year?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. Erl��uterungen zur Vereinbarung ��ber Vordrucke f��r die vertrags��rztliche Versorgung, Muster 1 (10)&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1672">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligations.</text>
<response varName="42241X32X1673">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of obligations.</text>
<response varName="42241X32X1674">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you responsible for the occupational health and safety of persons exposed to radioactive radiation during their working hours?</text>
<response varName="42241X32X1675">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you store the corresponding health records of persons exposed to radioactive radiation for at least 30 years after the end of their exposure to radiation and for 75 years after their date of birth? Do you delete these health records 100 years after their date of birth?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. �� 41 (3) R��ntgenverordnung, �� 64 (3) Strahlenschutzverordnung&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1676">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligations.</text>
<response varName="42241X32X1677">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of obligations.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1678">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data concern the donation of blood or related procedures?</text>
<response varName="42241X32X1679">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; Pursuant to �� 11 (1) Transfusionsgesetz, data concerning the donation of blood or related procedures normally has to be stored for at least 15 years and in a way that allows immediate access. However, if the data is no longer necessary for purposes of the Transfusionsgesetz, for the medical treatment of the donor or for purposes of risk management pursuant to the Arzneimittelgesetz, it must be deleted (note that these are exceptional cases, e.g. if the patient has died and the data is of no use for any of the purposes mentioned above).&#13;
Does your data system comply with these legal requirements?&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1680">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does the data concern hyperimmunization?</text>
<response varName="42241X32X1681">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; Pursuant to �� 11 (1) Transfusionsgesetz, data concerning hyperimmunization has to be stored for at least 20 years.&#13;
Does your data system comply with this requirement?&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1682">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligations.</text>
<response varName="42241X32X1683">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of obligations.</text>
<response varName="42241X32X1684">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the data necessary for traceability?</text>
<response varName="42241X32X1685">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; Pursuant to �� 11 (1) Transfusionsgesetz data concerning traceability has to be stored for at least 30 years.&#13;
Does your data system comply with this requirement?&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1686">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligations.</text>
<response varName="42241X32X1687">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of obligations.</text>
<response varName="42241X32X1688">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does the preserved data concern donors who have not donated blood at your donation establishment for at least 30 years?</text>
<response varName="42241X32X1689">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; If the data has been stored for more than 30 years since the last registered donation of the donor in this establishment, it must be made anonymous (�� 11 (1) Transfusionsgesetz).&#13;
Does your data system comply with this requirement?&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1690">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Note: You comply with your obligations.</text>
<response varName="42241X32X1691">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1692">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your establishment explant human organs or tissue?</text>
<response varName="42241X32X1693">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; Pursuant to �� 15 Transplantationsgesetz, certain documentation has to be stored for 30 years. After this period the data must be deleted or made anonymous.&#13;
Do you store documentation on the involvement of potential donors��� next of kin in making donation decisions for 30 years?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. �� 4 (4) Transplantationsgesetz&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1694">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligations.</text>
<response varName="42241X32X1695">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1696">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you store your documentation on explanting organs or tissue from dead foetuses and embryos, including records on information and the consent of the mother, for 30 years?&#13;
&#13;
&lt;u&gt;Note: &lt;/u&gt;Cf. �� 4a (2) Transplantationsgesetz&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1697">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligation.</text>
<response varName="42241X32X1698">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1699">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you store doctors' documentation of the diagnosis of clinical death of the donors for 30 years?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. �� 5 (2), (3) Transplantationsgesetz&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1700">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligation.</text>
<response varName="42241X32X1701">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1702">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you store documentation about the donor and their declaration of consent for 30 years?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. ���� 8 (2) 4, 8a 1 No. 4, 8b (1) and (2), 8c (1) No. 1 lit. b and (2) and (3), 8 (3) 2 Transplantationsgesetz&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1703">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligation.</text>
<response varName="42241X32X1704">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1705">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you store documentation about every tissue procurement and transfer and related measures as well as information on materials that have come in contact with this tissue for 30 years after the expiration date of the tissue?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt;&lt;em&gt; &lt;/em&gt;Cf. �� 8d (2) Transplantationsgesetz&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1706">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligation.</text>
<response varName="42241X32X1707">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1708">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is your establishment a hospital dealing with transplants of human organs or tissue?</text>
<response varName="42241X32X1709">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you preserve the doctor���s documentation on the transplanted tissue for 30 years after the date of the transplant?&#13;
This documentation has to include the identity of the donor, the date of the transplantation, the identity of the transplanting doctor, the description of the transplanted tissue, and the name of the tissue establishment the tissue came from.&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. ���� 15, 13a, 16a Transplantationsgesetz, �� 7 TPG-Gewebeverordnung</text>
<response varName="42241X32X1710">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you delete or make anonymous the documentation after 30 years?</text>
<response varName="42241X32X1711">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligation.</text>
<response varName="42241X32X1712">
<fixed>
<category>
<label>Click to continue</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.&#13;
&#13;
&lt;u&gt;Note: &lt;/u&gt;Cf. �� 15 (3) Transplantationsgesetz&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1713">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1714">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your medical data concern the use of X-rays?</text>
<response varName="42241X32X1715">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; Pursuant to �� 85 (1), (3) Strahlenschutzverordnung and �� 28 (1) (3) R��ntgenverordnung, certain data regarding the use of X-rays for medical examinations must be preserved for at least ten years; if they concern medical treatments, for as long as 30 years. The information to be kept is:&#13;
- result of interviews with the patient (regarding former application of radioactive substances, pregnancy etc);&#13;
- time, nature and purpose of the examination/treatment; - examined are of the body; - radiation exposure of the patient; - details on the radioactive substances used; - the medical diagnosis that justifies the use of radioactive substances in the case at hand; - the explanatory statement required by �� 81 (2) 2 Strahlenschutzverordnung; - results of any examination; - dosage and application rates of any treatment; - in case of treatment with irradiation facilities the corresponding protocol and plan. The data can be stored in an electronic form, see �� 115 (1) 1 Strahlenschutzverordnung and �� 43 (1) R��ntgenverordnung.&#13;
&#13;
Do you comply with these requirements?&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1716">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1753">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the documentation protected against access by unauthorized persons and unauthorized changes?</text>
<response varName="42241X32X1717">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your legal obligation.</text>
<response varName="42241X32X1718">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligation.</text>
<response varName="42241X32X1719">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you process your documentation with the help of data processing facilities?</text>
<response varName="42241X32X1720">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Can - during the storage period of 10 or 30 years - the information be made readable within a reasonable period of time?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; �� 28 (4) R��ntgenverordnung&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1721">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note: &lt;/u&gt;You comply with your obligation.</text>
<response varName="42241X32X1722">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligation.</text>
<response varName="42241X32X1723">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does the the preserved data allow an exact reproduction of the images and documentation?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; �� 28 (4) R��ntgenverordnung&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1724">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligation.</text>
<response varName="42241X32X1725">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligation.</text>
<response varName="42241X32X1726">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are subsequent changes to, or loss of, the stored X-ray images or documentation during the retention period possible?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; �� 28 (4) R��ntgenverordnung&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1727">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your obligation.</text>
<response varName="42241X32X1728">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligation.</text>
<response varName="42241X32X1729">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you save your patients��� personal data (name, place and date of birth, sex) findings, X-ray images or other parts of the documentation on data carriers?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Then �� 28 (5) R��ntgenverordnung applies&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1730">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are the author, place and time of the creation of the data on the data carrier identifiable?</text>
<response varName="42241X32X1731">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Notice: Infringement of legal obligation.</text>
<response varName="42241X32X1732">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are subsequent changes and additions to the data stored on the data carrier marked as such and tagged with the name of the author and time of the change/addition?</text>
<response varName="42241X32X1733">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligation</text>
<response varName="42241X32X1734">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Can the patient���s personal data stored on the data carrier be matched with the rest of the documentation concerning their X-ray examination/treatment during the retention period?</text>
<response varName="42241X32X1735">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your legal obligation.</text>
<response varName="42241X32X1736">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligation.</text>
<response varName="42241X32X1737">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does the data stored on data carriers include X-ray images?</text>
<response varName="42241X32X1738">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Is the basic X-ray image with its post-editing parameters and, in the case of a series of X-ray images the number of images, preserved on the data carrier?</text>
<response varName="42241X32X1739">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your legal obligation.</text>
<response varName="42241X32X1740">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligation.</text>
<response varName="42241X32X1741">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you transfer electronic data to other doctors/dentists involved in the treatment of the patient?</text>
<response varName="42241X32X1742">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Have you taken precautionary measures to ensure state-of-the-art data protection and data security for the transfer? If you send this data via the Internet, do you use encryption techniques?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. �� 28 (6) R��ntgenverordnung&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1743">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your legal obligation.</text>
<response varName="42241X32X1744">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligation.</text>
<response varName="42241X32X1745">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you store X-ray images of minors, and documentation on these X-ray examinations, until their 28th birthday?&#13;
&#13;
&lt;u&gt;Note: &lt;/u&gt;Cf. �� 28 (3) 3 R��ntgenverordnung&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1746">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your legal obligation.</text>
<response varName="42241X32X1747">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligations.</text>
<response varName="42241X32X1748">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you apply radioactive substances or radiation on persons for the purpose of medical research?</text>
<response varName="42241X32X1749">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; The documentation of information provided to the subject, their declaration of any previous applications of radioactivity, their consent to the treatment and the results of the treatment must be stored for at least 30 years, see �� 87 (5) Strahlenschutzverordnung and �� 28c (5) R��ntgenverordnung.&#13;
Do you comply with these requirements?&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1750">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your legal obligation.</text>
<response varName="42241X32X1751">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of legal obligation.</text>
<response varName="42241X32X1752">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your data concern genetic engineering operations?</text>
<response varName="42241X32X1754">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; ���� 2 ���� 2 ff. Gentechnik-Aufzeichnungsverordnung have introduced a number of obligations to document and preserve as well as numerous modalities for preservation.&#13;
Pursuant to �� 3 (1) documentations must not be made unreadable and any subsequent changes to the original data must be clearly highlighted.&#13;
�� 3 (2) allows electronic preservation under the condition that no subsequent changes of the content of the data medium are possible. During the retention period the data must be short term accessible. Pursuant to �� 4 the length of retention periods depend on the security level of the genetic engineering operations (for more details see �� 7 (1) Gentechnikgesetz): 10 years for operations with security level 1, 30 years for operations with security level 2-4 and releases of genetically modified organisms. Do you comply with these obligations?&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1755">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your legal obligation.</text>
<response varName="42241X32X1756">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Notice: Infringement of legal obligation.</text>
<response varName="42241X32X1757">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you run a reference institution for external quality assurance for laboratory medical examinations?</text>
<response varName="42241X32X1758">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you preserve documentation on determining the target results for five years?&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Cf. 'Richtlinie der Bundes��rztekammer zur Qualit��tssicherung laboratoriumsmedizinischer Untersuchungen' (Guidelines of the German Medical Association on Quality Assurance for laboratory medical examinations) E1-2, E2-2, E3-1 (3), E4-2, E5-2&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1759">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with your legal obligation.</text>
<response varName="42241X32X1760">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Infringement of obligations.</text>
<response varName="42241X32X1761">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with the sector-specific obligations laid down with regard to medical data.</text>
<response varName="42241X32X1340">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Your medical data system does not meet legal requirements. This may lead to liability or penalties regulated by the state.</text>
<response varName="42241X32X1341">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you an authorized manufacturer of medicinal products for human use?</text>
<response varName="42241X32X1339">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your documentation system comply with the necessary requirements?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; Directive 2001/83/EC contains the fundamental regulations for manufacturers of medicinal products for human use. Procedures for the authorization and supervision of medicinal products for human and veterinary use are laid down by Regulation (EC) No 726/2004.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1342">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. What requirements have to be complied with?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; You must establish and maintain a documentation system based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations performed.</text>
<text>Documents shall be clear, free from error and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be kept available, together with specific documents for the manufacture of each batch. That set of documents shall enable the history of the manufacture of each batch and the changes introduced during the development of an investigational medicinal product to be traced.</text>
<text>For a detailed overview, check the principles and guidelines of good manufacturing practice!������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 46 lit. l) Directive 2001/83/EC and Art. 9 Directive 2003/94/EC;</text>
<text>cf. EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4, Chapter 4&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1343">
<fixed>
<category>
<label>I understand the above statement</label>
<value>A1</value>
</category>
<category>
<label>How long does the documentation have to be retained?</label>
<value>A2</value>
</category>
<category>
<label>Do any orders exist with regard to storage specifications?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>How long does the documentation have to be retained for?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; For a medicinal product, the batch documentation must be retained for at least one year after the expiry date of the batches to which it relates or at least five years after the certification referred to in Article 51(3) of Directive 2001/83/EC, whichever is the longer period.</text>
<text>For an investigational medicinal product, the batch documentation shall be retained for at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used.��������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 9 Directive 2003/94/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1344">
<fixed>
<category>
<label>I understand the above statement</label>
<value>A1</value>
</category>
<category>
<label>Do any orders exist with regard to storage specifications?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are there any regulations covering storage specifications?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Yes. The sponsor, or marketing authorization holder, if different, shall be responsible for ensuring that records are retained as required for marketing authorization in accordance with Annex I to Directive 2001/83/EC, if required for a subsequent marketing authorization. In addition, data stored by electronic storage systems must be made readily available in legible form and be provided to the competent authorities at their request. Electronically stored data shall be protected by methods such as duplication or back-up and transfer onto another storage system, against loss or damage of data, and audit trails shall be maintained.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 9 Directive 2003/94/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1346">
<fixed>
<category>
<label>I understand the above statement</label>
<value>A1</value>
</category>
<category>
<label>How long does the documentation have to be retained?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your documentation system comply with the necessary requirements?</text>
<response varName="42241X32X1348">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; You infringe EU-law.</text>
<response varName="42241X32X1349">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you consider the special rules that address particularities of certain types of medicinal products?</text>
<response varName="42241X32X1350">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I do not know. What kind of products are addressed by special rules?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you engaged in manufacturing one of those products?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; There are special rules for example for�� medicinal products for children, advanced therapy medicinal products and orphan medicinal products.����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Regulation 1901/2006/EC; cf. Regulation 1394/2007/EC; cf. Regulation 141/2000/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1351">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you observe the special regulations covering different types of medicinal product?&#13;
&#13;
&lt;p&gt;&#13;
What has to be taken into account?&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; If you are engaged in manufacturing advanced therapy medicinal products, you have to ensure full traceability. In order to do so documents have to be kept for a minimum of thirty years after the expiry date of the product or longer by the marketing authorization holder.������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 15�� Regulation 1394/2007/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1352">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; Your documentation system complies with EU law. But be aware that EU Directives only set minimum standards, and individual national legislation must be observed</text>
<response varName="42241X32X1354">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; You infringe EU-law.</text>
<response varName="42241X32X1355">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you an authorized manufacturer of medicinal products for veterinary use?</text>
<response varName="42241X32X1356">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your documentation system comply with the necessary requirements?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Directive 2001/82/EC contains the fundamental rules for manufacturers of medicinal products for veterinary use.</text>
<text>&lt;u&gt;Hint:&lt;/u&gt; Procedures for the authorization and supervision of medicinal products for human and veterinary use are laid down by Regulation (EC) No 726/2004&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1357">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I do not know. What requirements have to be minded?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; You must keep detailed records of all veterinary medicinal products supplied, including samples, in accordance with the laws of the countries of destination. The following information a minimum shall be recorded in respect of each transaction, whether or not it is made for payment:</text>
<text>- date,</text>
<text>- name of the veterinary medicinal product,</text>
<text>- quantity supplied,</text>
<text>- name and address of the recipient,</text>
<text>- batch number.</text>
<text>Furthermore, you must establish and maintain a documentation system based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations performed.</text>
<text>Documents must be clear, free from error and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be kept available, together with specific documents for the manufacture of each batch. This set of documents must make it possible to trace the history of the manufacture of each batch.</text>
<text>For a detailed overview, check the principles and guidelines of good manufacturing practice!��������������������������������������������������������������������������������������������������������������������������������������������&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 50 lit. g) Directive 2001/82/EC; cf. Art. 50 lit. f) Directive 2001/82/EC and Art. 9 Directive 91/412/EEC; cf. EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4, Chapter 4&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1358">
<fixed>
<category>
<label>I understand the above statement</label>
<value>A1</value>
</category>
<category>
<label>How long does the documentation have to be retained?</label>
<value>A2</value>
</category>
<category>
<label>Do any orders exist with regard to storage specifications?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>How long must the documentation be retained for?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; The records required in Art. 50 lit. g) Directive 2001/82/EC shall be available for inspection by the competent authorities for a period of at least three years.</text>
<text>The batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates or at least five years after the certification referred to in Art. 55 (3) Directive 2001/82/EC, whichever is the longer period.������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art.�� 50 lit. g) Directive 2001/82/EC</text>
<text>cf. Art. 9 Directive 91/412/EEC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1359">
<fixed>
<category>
<label>I understand the above statement</label>
<value>A1</value>
</category>
<category>
<label>Do any orders exist with regard to storage specifications?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are there any regulations covering storage specifications?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Data stored by electronic storage systems must be made readily available in legible form, and shall be protected against loss or damage of data by methods such as duplication or back-up and transfer onto another storage system.��������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
Note: cf. Art. 9 Directive 91/412/EEC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1361">
<fixed>
<category>
<label>I understand the above statement</label>
<value>A1</value>
</category>
<category>
<label>How long does the documentation have to be retained?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your documentation system comply with the necessary requirements?</text>
<response varName="42241X32X1364">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Veterinary use:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Result:&lt;/u&gt; Your documentation system complies with EU law. But be aware that EU Directives only set minimum standards, and individual national legislation must be observed.&lt;/p&gt;</text>
<response varName="42241X32X1363">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Veterinary use:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; You infringe EU-law.&lt;/p&gt;</text>
<response varName="42241X32X1365">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are you engaged in clinical trials of medicinal product development?</text>
<response varName="42241X32X1366">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your documentation system comply with the necessary requirements?</text>
<response varName="42241X32X1367">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don���t know. What requirements have to be complied with?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your documentation system comply with the necessary requirements?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Art. 16ff. of Directive 2005/28/EC foresee documentation and record-keeping obligations for the entities managing and/or financing the clinical trialtrials and for the persons carrying itthem out for a period of at least five years after the completion of a clinical trial. Essentially, the documents shallshould show whether the investigator and the sponsor have complied with the principles and guidelines of good clinical practice and with the applicable requirements and, in particular, with Annex I to Directive 2001/83/EC.����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; cf. Art. 16ff Directive 2005/28/EC&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X32X1368">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Clinical Trials:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; Your documentation system complies with EU law. But be aware that EU Directives only set minimum standards, and individual national legislation must be observed.&lt;/p&gt;</text>
<response varName="42241X32X1369">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Clinical trials:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; You infringe EU-law.&lt;/p&gt;</text>
<response varName="42241X32X1370">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
</section>
<section id="33">
<sectionInfo>
<position>title</position>
<text>Monitoring - Non-Sector Specific Obligations</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>How can I ensure legibility?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; A suitable and reliable viewer for the invoice format should be available throughout the entire storage period.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<sectionInfo>
<position>before</position>
<text>Are format changes precluded by legislation?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Format changes are not precluded as long as the migrated data meets the requirements of authenticity, integrity and legibility.������������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; Member states may implement a provision which demands that the data guaranteeing authenticity, integrity and legibility of the invoice also must be stored by electronic means.&lt;/p&gt;</text>
<administration>self</administration>
</sectionInfo>
<question>
<text>Please choose one or more of the following sectors:</text>
<response varName="42241X33X1371SQ001">
<fixed>
<category>
<label>Tax law</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X33X1371SQ002">
<fixed>
<category>
<label>Commercial law</label>
<value>1</value>
</category>
</fixed>
</response>
<response varName="42241X33X1371SQ003">
<fixed>
<category>
<label>Personnel files and related data</label>
<value>1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please choose the level of regulation:</text>
<response varName="42241X33X1375">
<fixed>
<category>
<label>EU Level</label>
<value>A1</value>
</category>
<category>
<label>National Level</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Do you use e-invoices?&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Due to a lack of competence of the EU, legislation covering direct and indirect taxation is not wide-ragingly harmonized between the member states. There is a greater degree of harmonization in the field of Value Added Tax (VAT). The VAT Directive is an example of EU legislation which contains provisions for Digital Preservation actions.&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Directive 2010/45/EU, which had to be applied by member states from 1 January 2013, establishes equal treatment of paper and electronic invoices. Electronic invoicing is covered if the customer accepts receipt of invoices by electronic means (Art. 232 VAT Directive).&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X33X1376">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your invoice storage system comply with the necessary requirements?</text>
<response varName="42241X33X1377">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know. What are the requirements?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; The taxable person must be able to prove the authenticity of the invoice's origin, the integrity of its contents and ensure its legibility at all time between the point of issue and the end of the storage period.</text>
<response varName="42241X33X1378">
<fixed>
<category>
<label>I understand the above statement</label>
<value>A1</value>
</category>
<category>
<label>Are format changes precluded?</label>
<value>A2</value>
</category>
<category>
<label>How can I ensure legibility?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Are format changes precluded by legislation?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Format changes are not precluded as long as the migrated data meets the requirements of authenticity, integrity and legibility.������������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; Member states may implement a provision which demands that the data guaranteeing authenticity, integrity and legibility of the invoice also must be stored by electronic means.&lt;/p&gt;</text>
<response varName="42241X33X1379">
<fixed>
<category>
<label>I understand the above statement</label>
<value>A1</value>
</category>
<category>
<label>How can I ensure legibility?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>How can I ensure legibility?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; A suitable and reliable viewer for the invoice format should be available throughout the entire storage period.&lt;/p&gt;</text>
<response varName="42241X33X1381">
<fixed>
<category>
<label>I understand the above statement</label>
<value>A1</value>
</category>
<category>
<label>Are format changes precluded?</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Does your invoice storage system comply with the necessary requirements?</text>
<response varName="42241X33X1383">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please choose your country:&#13;
&#13;
&lt;p&gt;&#13;
How long must an invoice be stored for?&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Pursuant to Art. 247 (1) VAT Directive , the period is set by each member state.&lt;/p&gt;&#13;
&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X33X1384">
<fixed>
<category>
<label>Germany</label>
<value>A1</value>
</category>
<category>
<label>UK</label>
<value>A2</value>
</category>
<category>
<label>France</label>
<value>A3</value>
</category>
<category>
<label>USA</label>
<value>A4</value>
</category>
<category>
<label>Austria</label>
<value>A5</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt; 10 years (�� 14b I German VAT Act)&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X33X1385">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Explanation:&lt;/u&gt;�� 7 years (�� 11 (2) Austrian Federal VAT Act)&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X33X1386">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; National Law must be checked.</text>
<response varName="42241X33X1387">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; The invoice may be regarded as an insufficient piece of evidence. Besides, the burden of proof may be shifted. Furthermore, if there is court order to disclose a specific document, non-compliance may be punishable by law.</text>
<response varName="42241X33X1388">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; You do not have to follow the provisions for e-invoices. But there may be further provisions at EU level that have to be taken into consideration when Digital Preservation processes are carried out.</text>
<response varName="42241X33X1389">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Choose your country:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Obligations to document and keep the documentation generated may be found in various laws. There is no uniform legal record-keeping framework. Therefore, you must check national provisions.&lt;/p&gt;</text>
<response varName="42241X33X1390">
<fixed>
<category>
<label>Germany</label>
<value>A1</value>
</category>
<category>
<label>France</label>
<value>A2</value>
</category>
<category>
<label>Spain</label>
<value>A3</value>
</category>
<category>
<label>Austria</label>
<value>A4</value>
</category>
<category>
<label>Great Britain</label>
<value>A5</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; The provisions in the German Fiscal Code (AO) are the primary factors to consider. The Sales Tax Law (UStG) and the German Income Tax Act (EStG) are also of some relevance.&#13;
&#13;
&lt;u&gt;Notice:&lt;/u&gt; Those who have a legal obligation to keep accounts books also have to comply with the obligations to preserve documents. If you do not comply with the obligations to store these documents, you are in automatic infringement of your legal obligations to keep the books. The following examples illustrate the wide range of obligations to preserve documents. Please note that it is not possible to mention all applicable obligations here.&#13;
If you do not comply with legal obligations to keep accounts books, you could face the following sanctions if the requirements are not fulfilled:&#13;
- an insolvency offence pursuant to ���� 283 ff. German Criminal Code (StGB);&#13;
&#13;
��&#13;
- prosecution pursuant to the relevant provisions, ���� 399 ff. German Stock Corporation Act (AktG), �� 82 German Limited Liability Act (GmbHG), �� 147 German Cooperative Act (Genossenschaftsgesetz);&#13;
&#13;
��&#13;
- prosecution pursuant to �� 274 German Criminal Code (Document suppression);&#13;
&#13;
��&#13;
- being charged with fiscal or administrative offences, ���� 370, 378, 379 German Fiscal Code (AO).&#13;
&#13;
��&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Please identify if you comply with the following obligations. The following documents must be stored separately according to �� 147 (1), (3) AO:&#13;
(1) accounts and records, inventories, annual reports, situation reports, the opening balance sheet as well as operating instructions and other organizational documents needed to understand them;&#13;
&#13;
��&#13;
(2) trade or business letters received;&#13;
&#13;
��&#13;
(3) copies of trade or business letters sent;&#13;
&#13;
��&#13;
(4) accounting records;&#13;
&#13;
��&#13;
(4a) documents which are to be attached to a customs declaration made by means of a data-processing technique pursuant to Art. 77 (1) in conjunction with Art. 62 (2) of the German Customs Code, to the extent that the custom authorities elect not to have them submitted in accordance with Art. 77 (2) 1 of the Customs Code or have returned them following their submission;&#13;
&#13;
��&#13;
(5) other documents to the extent that these are of relevance for taxation. How long must the documents be stored for? The documents mentioned in clauses 1, 4, 4a above must be stored for a period of ten years, and the other documents for six years. Documents must be kept for as long as they are of relevance to taxes for which the assessment period has not yet expired (see �� 147 (3) AO). Please refer to �� 147 (2) AO for which forms of storage are acceptable. Pursuant to ���� 14 I, 14b UStG, all purchase invoices received by the business must be kept. Futhermore, a duplicate of all invoices issued by, or in the name of, the business must be kept. How long must the documents be stored for? Documents must be stored for ten years, starting with the end of the calendar year the invoice was issued in. Under certain conditions it is possible to store these documents electronically (see �� 14b (2), (3), (5) UStG).&#13;
&#13;
��&#13;
Note: Internal documents, such as calendars or work reports, which must not be given to the field auditor, need not be stored.&#13;
&#13;
��&#13;
&#13;
��</text>
<response varName="42241X33X1638">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Note: In fiscal law, there are strict requirements with regard to the retention of documents. Please identify if you comply with the following obligations. The following applies to invoices: Copies of invoices sent to customers must be stored in paper or in electronic form (see BOI number 4 of January 2007); paper originals of invoices received from suppliers must be retained; electronic storage is permitted for the retention of e-invoices. How long shall the documents be stored? In general, documents must be stored for six years. Pursuant to Art. L 102 B of the French Book of Fiscal Procedure, books, registers or receipts established in electronic format must be retained for a period of six years.</text>
<response varName="42241X33X1639">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please identify if you comply with the following obligations.&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Please confirm that you comply with these employer obligations to store the following documents: any invoices or replacement documents issued, any invoice copies or originals issued in compliance with Art. 2 and 2.1 of the Royal Decree 1496/2003, any invoices sent in accordance with Art. 2.3 of the Royal Decree 1496/2003, any supporting accounting documents and any import tax payment supporting documents. The retention period is given in the General Tax Law.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X33X1640">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Notice:&lt;/u&gt; Those who have a legal obligation to keep accounts books also have to comply with the obligations to preserve documents. If you do not comply with the obligations to store these documents, you are in automatic infringement of your legal obligations to keep the books. In addition, those who voluntarily keep accounts books are also obliged to comply with the obligations to preserve documents.&#13;
Please identify if you comply with the following obligations.&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Pursuant to the Federal Taxation Code (BAO), all documents which relate to accounts books must be stored. �� 139 (2) BAO makes provision for documents to be stored on data carriers if certain requirements are fulfilled. Pursuant to �� 139 (1) BAO, documents must be stored for seven years. If documents relate to property, this period is prolonged by a further five years.</text>
<response varName="42241X33X1641">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; With regard to financial records, the Companies Act 1985��and the VAT Act 1994��contain minimum legal retention periods. In general, records must be retained for six years from the end of the current financial year. More information are given in the field of Commercial Law. Please see there for general information.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X33X1642">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Commercial aw:&#13;
&lt;p&gt;&#13;
Please choose the level of regulation:&lt;/p&gt;</text>
<response varName="42241X33X1393">
<fixed>
<category>
<label>EU legislation</label>
<value>A1</value>
</category>
<category>
<label>National legislation</label>
<value>A2</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Note: EU-legislation comparable to �� 257 HGB?&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X33X1394">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Choose your country:&#13;
&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; Obligations to document and keep the documentation generated may be found in various laws. There is no uniform legal record-keeping framework. Therefore, you must check national provisions.&lt;/p&gt;</text>
<response varName="42241X33X1395">
<fixed>
<category>
<label>Germany</label>
<value>A1</value>
</category>
<category>
<label>Great Britain</label>
<value>A2</value>
</category>
<category>
<label>France</label>
<value>A3</value>
</category>
<category>
<label>Spain</label>
<value>A4</value>
</category>
<category>
<label>Austria</label>
<value>A5</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; The provisions of the German Commercial Code (HGB) must be taken into account.&#13;
&#13;
&lt;u&gt;1) Notice:&lt;/u&gt; Those who have a legal obligation to keep accounts books also have to comply with the obligations to preserve documents. 2) If you do not comply with the obligations to store these documents, you are in automatic infringement of your legal obligations to keep the books.&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; If you do not comply with the legal obligations to keep accounts books, you could face the following sanctions if the requirements are not fulfilled:&#13;
- an insolvency offense pursuant to ���� 283 ff. German Criminal Code (StGB);&#13;
- prosecution pursuant to the relevant provisions ���� 399 ff. German Stock Corporation Act (AktG), �� 82 German Limited Liability Act (GmbHG), �� 147 German Cooperative Act (Genossenschaftsgesetz); - prosecution pursuant to �� 274 German Criminal Code (Document suppression);- being charged with fiscal or administrative offences, ���� 370, 378, 379 German Fiscal Code (AO). Are you a trader?</text>
<response varName="42241X33X1631">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; The provisions of the German Commercial Code (HGB) must be taken into account.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X33X1632">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; The following examples illustrate the wide range of obligations to preserve documents. Please note that it is not possible to mention all applicable obligations here. Please confirm that you comply with the obligations.&#13;
&#13;
Pursuant to �� 257 (1), (4) HGB the following documents must be stored separately: (1) accounts and records, inventories, opening balance sheets, annual reports, situation reports, individual accounts, annual group accounts, group management reports as well as the operating instructions and other organizational documents needed for their comprehension; (2) trade letters received; (3) copies of trade letters sent; (4) accounting records. Please note: As employment is a commercial transaction, obligations to store documents can be based in commercial and tax law. Pursuant to �� 257 (1) numbers 2 and 3 HGB, documents which were generated in preparation of the actual employment starting must be stored. Notice: Data protection regulations must be born in mind. Please note: Pursuant to �� 257 (1) numbers 2 and 3 HGB, documents regarding contracts must also be stored.&#13;
&#13;
How long must the documents be stored for? Pursuant to �� 257 (4) HGB the documents mentioned in numbers 1 and 4 must be stored for a period of ten years, the other documents for six years. Please see �� 257 (3) HGB for which forms of storage are acceptable.&#13;
Note: Internal documents, such as calendars or work reports, which must not be given to the field auditor, need not to be stored. Pursuant to �� 257 (1), (4) HGB by analogy, special purpose financial statements must be stored for ten years because of an increase in share capital.</text>
<response varName="42241X33X1633">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; The Law of July 15, 2008 says that archiving is a legal obligation and defines what must be stored. The Code Civil defines the minimum retention periods for archiving. In commercial law, the retention period is usually ten years.</text>
<response varName="42241X33X1634">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please confirm that you comply with the following obligations.&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; Pursuant to Art. 30 of the Spanish Commercial Code, employers are obliged to retain accounting records, correspondence, documentation and supporting documents relating to their business for a period of six years. How long must the documents be stored for? The documents must be stored for a period of six years.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X33X1635">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Please confirm that you comply with the following obligations.&#13;
&#13;
&lt;u&gt;Note:&lt;/u&gt; 1) �� 212 Austrian Commercial Code (UGB) contains the retention periods for documents. The following documents must be stored: inventories, opening balance sheets, annual reports, business letters received, copies of business letters sent and accounting records. In principle, documents must be stored for seven years. Documents must be stored separately and in an organized way. Pursuant to �� 190 (5) UGB, data carriers can be used for the keeping of accounts books and storing business letters.&#13;
2) If the obligations are not fulfilled, the business may face sanctions. These can be imposed by the commercial register court audit requirements, penalty payments, corporate accounting regulations, liability issues, bankruptcy laws, provisions of the penal code, and tax laws. How long must the documents be stored for? In principle, the documents must be stored for seven years.&#13;
&#13;
&lt;u&gt;Notice:&lt;/u&gt; Those who have a legal obligation to keep accounts books also have to comply with the obligations to preserve documents If you do not comply with the obligations to store these documents, you are in automatic infringement of your legal obligations to keep the books.</text>
<response varName="42241X33X1636">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; Many pieces of legislation and regulation exist which give the required retention periods for documents (one of the most important is the Limitation Act 1980, which applies to England and Wales). The issue is complex. There are useful publications which identify some retention requirements; for example, 'The ICSA Guide to Document Retention' lists the retention requirements for different areas of law, e.g. company law. In general, UK legislation does not state the format to be used for storage.&#13;
&#13;
&lt;p&gt;&#13;
��&lt;/p&gt;</text>
<response varName="42241X33X1637">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Personnel files and related data:&#13;
&lt;p&gt;&#13;
Do you want to process personnel files and related data?&lt;/p&gt;</text>
<response varName="42241X33X1398">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did you observe restrictions on systems managing such files?</text>
<response varName="42241X33X1399">
<fixed>
<category>
<label>Yes</label>
<value>A1</value>
</category>
<category>
<label>No</label>
<value>A2</value>
</category>
<category>
<label>I don't know. What kind of restrictions exist?</label>
<value>A3</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Did you observe restrictions on systems managing such files?&#13;
&lt;p&gt;&#13;
&lt;u&gt;Explanation:&lt;/u&gt; Current systems that manage these files electronically, facilitate the processing of personal data and thus have to comply with data protection laws.��������������������������������������������������������������������������������������������������������������������������������������������������������������������������&lt;/p&gt;&#13;
&lt;p&gt;&#13;
&lt;u&gt;Note:&lt;/u&gt; Moreover, member states' labour laws might foresee that, in order for such systems to be legally admissible, employees or a trades union may need to approve them.&lt;/p&gt;</text>
<response varName="42241X33X1400">
<fixed>
<category>
<label>Yes</label>
<value>Y</value>
</category>
<category>
<label>No</label>
<value>N</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You comply with the provisions regulating personnel files and related data.</text>
<response varName="42241X33X1401">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>Personnel files and related data:&#13;
&lt;p&gt;&#13;
&lt;u&gt;Notice:&lt;/u&gt; There might be a breach of data protection law (check data protection part).&lt;/p&gt;</text>
<response varName="42241X33X1402">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
<question>
<text>&lt;u&gt;Note:&lt;/u&gt; You don't have to follow provisions that regulate personnel files and related data.</text>
<response varName="42241X33X1403">
<fixed>
<category>
<label>Click to proceed</label>
<value>A1</value>
</category>
</fixed>
</response>
</question>
</section>
</questionnaire>