Difference between revisions of "Core Requirements"

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|rowspan="2"|Bread & Butter
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Categories​​​
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Item​ ​Toolbox item
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              <strong>Research team</strong> </td>
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Research team ​ 1 Process owner must be identified for the Quality System ​1.5.2.3​
            <td class="ms-rteTableOddCol-2" style="width: 1%;">1</td>
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2 Communication process must be in place ​1.2
            <td class="ms-rteTableEvenCol-2">Process owner must be identified for the Quality&#160;System</td>
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​ ​
              <a href="/sites/EQIPD/EQIPD%20QS/Process%20owner.aspx">​1.5.2.3​</a><br/></td>
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​Quality culture ​
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3 The research unit must have defined quality objectives ​1.1
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">2</td>
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4 All activities must comply with relevant legislation and policies ​1.4.2
            <td class="ms-rteTableOddCol-2">Communication process must be in place</td>
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5 The research unit must have a procedure to act upon concerns of potential misconduct ​4.2.3​
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">​<a href="/sites/EQIPD/EQIPD%20QS/Scope.aspx">1.2</a><br/></td>
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​ ​
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​​Data integrity ​ ​ ​ 6
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Generation, handling and changes to data records must be documented ​2.3.1​
            <td class="ms-rteTableEvenCol-2" style="width: 6%;"><br/></td>
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7 Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs ​3.1.3
            <td class="ms-rteTableOddCol-2" style="width: 1%;">
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8
              <strong>&#160;</strong></td>
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Reported research outcomes must be traceable to experimental data ​3.1.2.1
            <td class="ms-rteTableEvenCol-2"></td>
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9
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Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​
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​2.4
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​ ​
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​​​Research processes ​ ​ ​ ​ 10 Investigator must declare in advance whether a study is intended to inform a formal knowledge claim ​2.1.4
              <strong>​Quality culture</strong> <br/> <br/></td>
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11
            <td class="ms-rteTableOddCol-2" style="width: 1%;">3</td>
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All personnel involved in research must have adequate training and competence to perform assigned tasks ​3.2.1
            <td class="ms-rteTableEvenCol-2">The research unit must have defined quality objectives</td>
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12 Protocols for experimental methods must be available ​3.5.2
            <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%; text-align: center;">​<a href="/sites/EQIPD/EQIPD%20QS/Mission.aspx" style="text-align: center;">1.1</a><br/></td>
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13 Adequate handling and storage of samples and materials must be ensured ​3.3.3
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14 Research equipment and tools must be suitable for intended use and ensure data integrity ​3.3.2​
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​ ​
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">4</td>
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​Continuous performance ​ ​ 15 Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data
            <td class="ms-rteTableOddCol-2">All activities must comply with relevant legislation and policies</td>
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4.1.1​​
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">​<a href="/sites/EQIPD/EQIPD%20QS/Adherence%20to%20legal%20and%20regulatory%20considerations.aspx">1.4.2</a><br/></td>
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16
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Critical incidents and errors during study conduct must be analyzed and appropriately managed ​4.2.2
        <tr class="ms-rteTableOddRow-2">
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17 An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">5</td>
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​4.1.2
            <td class="ms-rteTableOddCol-2">The research unit must have a procedure to act upon concerns of potential&#160;misconduct</td>
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​ ​
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">​<a href="/sites/EQIPD/EQIPD%20QS/Responsible%20conduct%20of%20research.aspx">4.2.3​</a><br/></td>
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Sustainability 18 Resources for sustaining the EQIPD Quality System must be available
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​1.5.5​​
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              <strong>&#160;</strong></td>
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Back to the [[EQIPD Framework]]​.​​​​
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              <strong>​​Data integrity</strong> ​ ​ ​</td>
 
            <td class="ms-rteTableOddCol-2" style="width: 1%;">6<br/></td>
 
            <td class="ms-rteTableEvenCol-2">Generation, handling and changes to data records must be documented</td>
 
            <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%; text-align: center;">​<a href="/sites/EQIPD/EQIPD%20QS/Generation,%20recording,%20handling%20and%20archiving%20of%20raw%20data.aspx">2.3.1​</a><br/></td>
 
        </tr>
 
        <tr class="ms-rteTableEvenRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">7</td>
 
            <td class="ms-rteTableOddCol-2">Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs</td>
 
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">​<a href="/sites/EQIPD/EQIPD%20QS/Data%20security.aspx">3.1.3</a><br/></td>
 
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        <tr class="ms-rteTableOddRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">8<br/></td>
 
            <td class="ms-rteTableOddCol-2">Reported research outcomes must be traceable to experimental data</td>
 
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">
 
              <a href="/sites/EQIPD/EQIPD%20QS/Traceability%20of%20data%20and%20any%20person%20having%20impact%20on%20data.aspx">​3.1.2.1</a><br/></td>
 
        </tr>
 
        <tr class="ms-rteTableEvenRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">9</td>
 
            <td class="ms-rteTableOddCol-2">
 
              <div>Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​<br/></div>
 
            </td>
 
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">​<a href="/sites/EQIPD/EQIPD%20QS/Reporting.aspx">2.4</a><br/></td>
 
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        <tr class="ms-rteTableOddRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 6%;">
 
              <strong>&#160;</strong></td>
 
            <td class="ms-rteTableOddCol-2" style="width: 1%;">
 
              <strong>&#160;</strong></td>
 
            <td class="ms-rteTableEvenCol-2"></td>
 
            <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%;"><br/></td>
 
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            <td class="ms-rteTableEvenCol-2" rowspan="5" style="width: 6%;">
 
              <strong>​​​Research processes</strong> ​ ​ ​ ​</td>
 
            <td class="ms-rteTableOddCol-2" style="width: 1%;">10</td>
 
            <td class="ms-rteTableEvenCol-2">Investigator must declare in advance whether a study is intended to inform a formal knowledge claim</td>
 
            <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%; text-align: center;">
 
              <a href="/sites/EQIPD/EQIPD%20QS/Purpose%20of%20research.aspx">​2.1.4</a><br/></td>
 
        </tr>
 
        <tr class="ms-rteTableOddRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">11<br/></td>
 
            <td class="ms-rteTableOddCol-2">All personnel involved in research must have adequate training and competence to perform assigned tasks</td>
 
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">​<a href="/sites/EQIPD/EQIPD%20QS/General%20guidance%20on%20training.aspx">3.2.1</a><br/></td>
 
        </tr>
 
        <tr class="ms-rteTableEvenRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">12</td>
 
            <td class="ms-rteTableOddCol-2">Protocols for experimental methods must be available</td>
 
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">
 
              <a href="/sites/EQIPD/EQIPD%20QS/Protocols%20for%20methods%20and%20assays.aspx">​3.5.2</a><br/></td>
 
        </tr>
 
        <tr class="ms-rteTableOddRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">13</td>
 
            <td class="ms-rteTableOddCol-2">Adequate handling and storage of samples and materials must be ensured</td>
 
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">
 
              <a href="/sites/EQIPD/EQIPD%20QS/Management%20of%20research%20materials%20and%20reagents.aspx">​3.3.3</a><br/></td>
 
        </tr>
 
        <tr class="ms-rteTableEvenRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">14</td>
 
            <td class="ms-rteTableOddCol-2">Research equipment and tools must be suitable for intended use and ensure data integrity</td>
 
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">
 
              <a href="/sites/EQIPD/EQIPD%20QS/Processes%20to%20enable%20computerized%20and%20non-computerized%20systems%20being%20suitable%20for%20intended%20use.aspx">​3.3.2​</a><br/></td>
 
        </tr>
 
        <tr class="ms-rteTableOddRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 6%;">
 
              <strong>&#160;</strong></td>
 
            <td class="ms-rteTableOddCol-2" style="width: 1%;">
 
              <strong>&#160;</strong></td>
 
            <td class="ms-rteTableEvenCol-2"></td>
 
            <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%;"></td>
 
        </tr>
 
        <tr class="ms-rteTableEvenRow-2">
 
            <td class="ms-rteTableEvenCol-2" rowspan="3" style="width: 6%;">
 
              <strong>​Continuous performance</strong> ​ ​</td>
 
            <td class="ms-rteTableOddCol-2" style="width: 1%;">15</td>
 
            <td class="ms-rteTableEvenCol-2">Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br/></td>
 
            <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%; text-align: center;">
 
              <a href="/sites/EQIPD/EQIPD%20QS/Risk%20assessment.aspx">4.1.1​​</a><br/></td>
 
        </tr>
 
        <tr class="ms-rteTableOddRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">16<br/></td>
 
            <td class="ms-rteTableOddCol-2">Critical incidents and errors during study conduct must be analyzed and appropriately managed</td>
 
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">
 
              <a href="/sites/EQIPD/EQIPD%20QS/Error%20and%20incident%20management.aspx">​4.2.2</a><br/></td>
 
        </tr>
 
        <tr class="ms-rteTableEvenRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 1%;">17</td>
 
            <td class="ms-rteTableOddCol-2">An approach must be in place to monitor the performance of the EQIPD Quality&#160;System, and address identified issues​<br/></td>
 
            <td class="ms-rteTableEvenCol-2" colspan="1" style="width: 5%; text-align: center;">​<a href="/sites/EQIPD/EQIPD%20QS/Self%20assessment.aspx">4.1.2</a><br/></td>
 
        </tr>
 
        <tr class="ms-rteTableOddRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 6%;">
 
              <strong>&#160;</strong></td>
 
            <td class="ms-rteTableOddCol-2" style="width: 1%;">
 
              <strong>&#160;</strong></td>
 
            <td class="ms-rteTableEvenCol-2"></td>
 
            <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%;"></td>
 
        </tr>
 
        <tr class="ms-rteTableEvenRow-2">
 
            <td class="ms-rteTableEvenCol-2" style="width: 6%;">
 
              <strong>Sustainability</strong></td>
 
            <td class="ms-rteTableOddCol-2" style="width: 1%;">18</td>
 
            <td class="ms-rteTableEvenCol-2">Resources for sustaining the EQIPD Quality&#160;System must be available<br/></td>
 
            <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%; text-align: center;">​<a href="/sites/EQIPD/EQIPD%20QS/Sustainability.aspx">1.5.5​​</a><br/></td>
 
        </tr>
 
      </tbody>
 
  </table>
 
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</div>
 
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  <br/>
 
  <p>Back to the&#160;[[EQIPD Framework]]​.​​​​<br/></p>
 
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Revision as of 15:07, 3 September 2020

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Categories​​​ Item​ ​Toolbox item ​

	​	​

Research team ​ 1 Process owner must be identified for the Quality System ​1.5.2.3​ 2 Communication process must be in place ​1.2 ​

	​	​

​Quality culture ​ ​ 3 The research unit must have defined quality objectives ​1.1 4 All activities must comply with relevant legislation and policies ​1.4.2 5 The research unit must have a procedure to act upon concerns of potential misconduct ​4.2.3​

	 	​	​

​​Data integrity ​ ​ ​ 6 Generation, handling and changes to data records must be documented ​2.3.1​ 7 Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs ​3.1.3 8 Reported research outcomes must be traceable to experimental data ​3.1.2.1 9 Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​ ​2.4

	 	​	​

​​​Research processes ​ ​ ​ ​ 10 Investigator must declare in advance whether a study is intended to inform a formal knowledge claim ​2.1.4 11 All personnel involved in research must have adequate training and competence to perform assigned tasks ​3.2.1 12 Protocols for experimental methods must be available ​3.5.2 13 Adequate handling and storage of samples and materials must be ensured ​3.3.3 14 Research equipment and tools must be suitable for intended use and ensure data integrity ​3.3.2​

	 	​	​

​Continuous performance ​ ​ 15 Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data 4.1.1​​ 16 Critical incidents and errors during study conduct must be analyzed and appropriately managed ​4.2.2 17 An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​ ​4.1.2

	 	​	​

Sustainability 18 Resources for sustaining the EQIPD Quality System must be available ​1.5.5​​

Back to the EQIPD Framework​.​​​​