Difference between revisions of "Core Requirements"
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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]] | ||
| − | | - | + | |[https://paasp.sharepoint.com/:w:/s/EQIPD/Ecmg1s58CM1Nssq_Wv3-Ei8BfcCMqxgQcRzesGy9a5gdRg?e=PbqvhE Study protocol] |
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|11 | |11 | ||
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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]] | ||
| − | | | + | |[https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV Protocols for experimental methods] |
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|13 | |13 | ||
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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]] | ||
| − | | - | + | |[https://paasp.sharepoint.com/:w:/s/EQIPD/Ecmg1s58CM1Nssq_Wv3-Ei8BfcCMqxgQcRzesGy9a5gdRg?e=PbqvhE Study protocol] and [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template] |
|- | |- | ||
|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]] | ||
| − | | - | + | |[https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 error reporting template] |
|- | |- | ||
|17 | |17 | ||
Revision as of 14:51, 30 November 2020
| Categories | No | Core Requirement | Toolbox reference | EQIPD provided 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 | Documentation 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 | Study protocol |
| 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 | Protocols for experimental methods | |
| 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 | Study protocol and Risk assessment template |
| 16 | Critical incidents and errors during study conduct must be analyzed and appropriately managed | 4.2.2 Error and incident management | error reporting template | |
| 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 | - |
*The provided templates are suggestions which may be used. However, their use is not a requirement, the reuiqrement is the documentation and description associated with the Core Requirement.
For information on required documentation within EQIPD please visit: Documentation in EQIPD
Back to the EQIPD Quality System.
