Difference between revisions of "Core Requirements"
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|'''Core Requirement''' | |'''Core Requirement''' | ||
|'''Toolbox reference''' | |'''Toolbox reference''' | ||
| − | |''' | + | |'''EQIPD required stand-alone document with links to templates''' |
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|rowspan="2"|'''Research team''' | |rowspan="2"|'''Research team''' | ||
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|Communication process must be in place | |Communication process must be in place | ||
|[[1.2 Scope]] | |[[1.2 Scope]] | ||
| − | | | + | |[https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ|Communication plan] |
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|rowspan="3"|'''Quality culture''' | |rowspan="3"|'''Quality culture''' | ||
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|The research unit must have defined quality objectives | |The research unit must have defined quality objectives | ||
|[[1.1 Mission]] | |[[1.1 Mission]] | ||
| − | | | + | |[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T|Mission statement] |
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|Generation, handling and changes to data records must be documented | |Generation, handling and changes to data records must be documented | ||
|[[2.3.1 Generation, recording, handling and archiving of raw data]] | |[[2.3.1 Generation, recording, handling and archiving of raw data]] | ||
| − | |rowspan="3"| | + | |rowspan="3"|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T|Documentation plan] |
| − | Documentation | ||
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|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim | |Investigator must declare in advance whether a study is intended to inform a formal knowledge claim | ||
|[[2.1.4 Purpose of research]] | |[[2.1.4 Purpose of research]] | ||
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|Protocols for experimental methods must be available | |Protocols for experimental methods must be available | ||
|[[3.5.2 Protocols for methods and assays]] | |[[3.5.2 Protocols for methods and assays]] | ||
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|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data | |Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data | ||
|[[4.1.1 Risk assessment]] | |[[4.1.1 Risk assessment]] | ||
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|16 | |16 | ||
|Critical incidents and errors during study conduct must be analyzed and appropriately managed | |Critical incidents and errors during study conduct must be analyzed and appropriately managed | ||
|[[4.2.2 Error and incident management]] | |[[4.2.2 Error and incident management]] | ||
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|17 | |17 | ||
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues | |An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues | ||
|[[4.1.2 Self assessment]] | |[[4.1.2 Self assessment]] | ||
| − | | | + | |[https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H|Self assessment] |
| − | Self assessment | ||
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|'''Sustainability''' | |'''Sustainability''' | ||
Revision as of 10:04, 27 November 2020
| Categories | No | Core Requirement | Toolbox reference | EQIPD required stand-alone document with links to templates |
| Research team | 1 | Process owner must be identified for the Quality System | 1.5.2.3 Process owner | - |
| 2 | Communication process must be in place | 1.2 Scope | Communication plan] | |
| Quality culture | 3 | The research unit must have defined quality objectives | 1.1 Mission | Mission statement] |
| 4 | All activities must comply with relevant legislation and policies | 1.4.2 Adherence to legal and regulatory considerations | - | |
| 5 | The research unit must have a procedure to act upon concerns of potential misconduct | 4.2.3 Responsible conduct of research | - | |
| Data integrity | 6 | Generation, handling and changes to data records must be documented | 2.3.1 Generation, recording, handling and archiving of raw data | plan |
| 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 Data security | ||
| 8 | Reported research outcomes must be traceable to experimental data | 3.1.2.1 Traceability of data and any person having impact on data | ||
| 9 | Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome | 2.4 Reporting | - | |
| Research processes | 10 | Investigator must declare in advance whether a study is intended to inform a formal knowledge claim | 2.1.4 Purpose of research | - |
| 11 | All personnel involved in research must have adequate training and competence to perform assigned tasks | 3.2.1 General guidance on training | - | |
| 12 | Protocols for experimental methods must be available | 3.5.2 Protocols for methods and assays | - | |
| 13 | Adequate handling and storage of samples and materials must be ensured | 3.3.3 Management of research materials and reagents | - | |
| 14 | Research equipment and tools must be suitable for intended use and ensure data integrity | 3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use | - | |
| Continuous performance | 15 | Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data | 4.1.1 Risk assessment | - |
| 16 | Critical incidents and errors during study conduct must be analyzed and appropriately managed | 4.2.2 Error and incident management | - | |
| 17 | An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues | 4.1.2 Self assessment | Self assessment] | |
| Sustainability | 18 | Resources for sustaining the EQIPD Quality System must be available | 1.5.5 Sustainability | - |
Back to the EQIPD Quality System.
