|
|
Line 1: |
Line 1: |
− | <div>
| + | {| class="wikitable" |
− | <table cellspacing="0" class="ms-rteTable-2" style="width: 62%;">
| + | |Shopping List |
− | <tbody>
| + | |- |
− | <tr class="ms-rteTableEvenRow-2">
| + | |rowspan="2"|Bread & Butter |
− | <td class="ms-rteTableEvenCol-2" style="width: 6%;">
| + | |Pie |
− | <strong>Categories</strong></td>
| + | |Buns |
− | <td class="ms-rteTableOddCol-2" style="width: 1%;"> <br/></td>
| + | |Danish |
− | <td class="ms-rteTableEvenCol-2" style="width: 33.333333333333336%;">
| + | |colspan="2"|Croissant |
− | <strong>Item</strong></td>
| + | |- |
− | <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%;"><strong>Toolbox item</strong><br/></td>
| + | |Cheese |
− | </tr>
| + | |colspan="2"|Ice cream |
− | <tr class="ms-rteTableOddRow-2">
| + | |Butter |
− | <td class="ms-rteTableEvenCol-2" style="width: 6%;"><br/></td>
| + | |Yogurt |
− | <td class="ms-rteTableOddCol-2" style="width: 1%;">
| + | |
− | <strong> </strong></td>
| + | |
− | <td class="ms-rteTableEvenCol-2"></td>
| + | |
− | <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%;"><br/></td>
| + | Categories |
− | </tr>
| + | Item Toolbox item |
− | <tr class="ms-rteTableEvenRow-2">
| + | |
− | <td class="ms-rteTableEvenCol-2" rowspan="2" style="width: 6%;">
| + | |
− | <strong>Research team</strong> </td>
| + | 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>
| + | 2 Communication process must be in place 1.2 |
− | <td class="ms-rteTableEvenCol-2">Process owner must be identified for the Quality System</td>
| + | |
− | <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%; text-align: center;">
| + | |
− | <a href="/sites/EQIPD/EQIPD%20QS/Process%20owner.aspx">1.5.2.3</a><br/></td>
| + | Quality culture |
− | </tr>
| + | |
− | <tr class="ms-rteTableOddRow-2">
| + | 3 The research unit must have defined quality objectives 1.1 |
− | <td class="ms-rteTableEvenCol-2" style="width: 1%;">2</td>
| + | 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>
| + | 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>
| + | |
− | </tr>
| + | Data integrity 6 |
− | <tr class="ms-rteTableEvenRow-2">
| + | Generation, handling and changes to data records must be documented 2.3.1 |
− | <td class="ms-rteTableEvenCol-2" style="width: 6%;"><br/></td>
| + | 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%;">
| + | 8 |
− | <strong> </strong></td>
| + | Reported research outcomes must be traceable to experimental data 3.1.2.1 |
− | <td class="ms-rteTableEvenCol-2"></td>
| + | 9 |
− | <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%;"></td>
| + | Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome |
− | </tr>
| + | 2.4 |
− | <tr class="ms-rteTableOddRow-2">
| + | |
− | <td class="ms-rteTableEvenCol-2" rowspan="3" style="width: 6%;">
| + | 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>
| + | 11 |
− | <td class="ms-rteTableOddCol-2" style="width: 1%;">3</td>
| + | 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>
| + | 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>
| + | 13 Adequate handling and storage of samples and materials must be ensured 3.3.3 |
− | </tr>
| + | 14 Research equipment and tools must be suitable for intended use and ensure data integrity 3.3.2 |
− | <tr class="ms-rteTableEvenRow-2">
| + | |
− | <td class="ms-rteTableEvenCol-2" style="width: 1%;">4</td>
| + | 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>
| + | 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>
| + | 16 |
− | </tr>
| + | Critical incidents and errors during study conduct must be analyzed and appropriately managed 4.2.2 |
− | <tr class="ms-rteTableOddRow-2">
| + | 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>
| + | 4.1.2 |
− | <td class="ms-rteTableOddCol-2">The research unit must have a procedure to act upon concerns of potential misconduct</td>
| + | |
− | <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>
| + | Sustainability 18 Resources for sustaining the EQIPD Quality System must be available |
− | </tr>
| + | 1.5.5 |
− | <tr class="ms-rteTableEvenRow-2">
| + | |} |
− | <td class="ms-rteTableEvenCol-2" style="width: 6%;">
| + | |
− | <strong> </strong></td>
| + | Back to the [[EQIPD Framework]]. |
− | <td class="ms-rteTableOddCol-2" style="width: 1%;">
| |
− | <strong> </strong></td>
| |
− | <td class="ms-rteTableEvenCol-2"></td>
| |
− | <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%;"></td>
| |
− | </tr>
| |
− | <tr class="ms-rteTableOddRow-2">
| |
− | <td class="ms-rteTableEvenCol-2" rowspan="4" style="width: 6%;">
| |
− | <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>
| |
− | </tr>
| |
− | <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>
| |
− | </tr>
| |
− | <tr class="ms-rteTableOddRow-2">
| |
− | <td class="ms-rteTableEvenCol-2" style="width: 6%;">
| |
− | <strong> </strong></td>
| |
− | <td class="ms-rteTableOddCol-2" style="width: 1%;">
| |
− | <strong> </strong></td>
| |
− | <td class="ms-rteTableEvenCol-2"></td>
| |
− | <td class="ms-rteTableOddCol-2" colspan="1" style="width: 5%;"><br/></td>
| |
− | </tr>
| |
− | <tr class="ms-rteTableEvenRow-2">
| |
− | <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> </strong></td>
| |
− | <td class="ms-rteTableOddCol-2" style="width: 1%;">
| |
− | <strong> </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 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> </strong></td>
| |
− | <td class="ms-rteTableOddCol-2" style="width: 1%;">
| |
− | <strong> </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 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>
| |
− | <br/>
| |
− | </div>
| |
− | <div>
| |
− | <br/>
| |
− | <p>Back to the [[EQIPD Framework]].<br/></p>
| |
− | <br/>
| |
− | <br/>
| |
− | <br/>
| |
− | <br/>
| |
− | </div>
| |
− | <br/>
| |
− | <br/>
| |
− | <br/>
| |
− | <br/>
| |