Documentation in EQIPD
Revision as of 12:52, 30 November 2020 by Bjoerngerlach (talk | contribs)
| Categories | No | Core Requirement | Toolbox reference | EQIPD required stand-alone document* | Required documentation* |
| 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 | Communication plan | - | |
| Quality culture | 3 | The research unit must have defined quality objectives | 1.1 | Mission statement | - |
| 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 | 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 | - | ||
| 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 | Self assessment | - | |
| Sustainability | 18 | Resources for sustaining the EQIPD Quality System must be available | 1.5.5 | - | - |
*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.
Back to the EQIPD Quality System.
