Difference between revisions of "Core Requirements"
| Line 29: | Line 29: | ||
|Data integrity | |Data integrity | ||
|6 | |6 | ||
| − | Generation, handling and changes to data records must be documented 2.3.1 | + | |Generation, handling and changes to data records must be documented |
| − | 7 Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs | + | |2.3.1 |
| − | 8 | + | |7 |
| − | Reported research outcomes must be traceable to experimental data | + | |Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs |
| − | 9 | + | |3.1.3 |
| − | Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome | + | |8 |
| − | + | |Reported research outcomes must be traceable to experimental data | |
| − | + | |3.1.2.1 | |
| − | Research processes | + | |9 |
| − | 11 | + | |Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome |
| − | All personnel involved in research must have adequate training and competence to perform assigned tasks | + | |2.4 |
| − | 12 Protocols for experimental methods must be available | + | |Research processes |
| − | 13 Adequate handling and storage of samples and materials must be ensured | + | |10 |
| − | 14 Research equipment and tools must be suitable for intended use and ensure data integrity | + | |Investigator must declare in advance whether a study is intended to inform a formal knowledge claim |
| − | + | |2.1.4 | |
| − | + | |11 | |
| − | 4.1. | + | |All personnel involved in research must have adequate training and competence to perform assigned tasks |
| − | 16 | + | |3.2.1 |
| − | Critical incidents and errors during study conduct must be analyzed and appropriately managed | + | |12 |
| − | 17 An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues | + | |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 | ||
| + | |Sustainability | ||
| + | |18 | ||
| + | |Resources for sustaining the EQIPD Quality System must be available | ||
| + | |1.5.5 | ||
|} | |} | ||
Back to the [[EQIPD Framework]]. | Back to the [[EQIPD Framework]]. | ||
Revision as of 07:38, 4 September 2020
| Categories | No | Item | Toolbox item | ||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||
| Quality culture
|3 |
The research unit must have defined quality objectives | 1.1 | |||||||||||||||||||||||||||||||||||||
| 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 | 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 |
Sustainability | 18 | Resources for sustaining the EQIPD Quality System must be available
|1.5.5 |
Back to the EQIPD Framework.
