Difference between revisions of "Core Requirements"
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|'''Categories''' | |'''Categories''' | ||
|'''No''' | |'''No''' | ||
| − | |''' | + | |'''Core Requirement''' |
|'''Toolbox reference''' | |'''Toolbox reference''' | ||
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|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome | |Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome | ||
| − | |2.4 | + | |[[2.4 Reporting]] |
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|rowspan="5"|'''Research processes''' | |rowspan="5"|'''Research processes''' | ||
Revision as of 07:56, 4 September 2020
| Categories | No | Core Requirement | Toolbox reference |
| 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 | |
| Quality culture | 3 | The research unit must have defined quality objectives | 1.1 Mission |
| 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 |
| 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 | |
| Sustainability | 18 | Resources for sustaining the EQIPD Quality System must be available | 1.5.5 Sustainability |
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