Difference between revisions of "Core Requirements"
| Line 12: | Line 12: | ||
|2 | |2 | ||
|Communication process must be in place | |Communication process must be in place | ||
| − | |1.2 | + | |[[1.2 Scope]] |
|- | |- | ||
|rowspan="3"|'''Quality culture''' | |rowspan="3"|'''Quality culture''' | ||
|3 | |3 | ||
|The research unit must have defined quality objectives | |The research unit must have defined quality objectives | ||
| − | |1.1 | + | |[[1.1 Mission]] |
|- | |- | ||
|4 | |4 | ||
|All activities must comply with relevant legislation and policies | |All activities must comply with relevant legislation and policies | ||
| − | |1.4.2 | + | |[[1.4.2 Adherence to legal and regulatory considerations]] |
|- | |- | ||
|5 | |5 | ||
|The research unit must have a procedure to act upon concerns of potential misconduct | |The research unit must have a procedure to act upon concerns of potential misconduct | ||
| − | |4.2. | + | |[[4.2.3 Responsible conduct of research]] |
|- | |- | ||
|rowspan="4"|'''Data integrity''' | |rowspan="4"|'''Data integrity''' | ||
|6 | |6 | ||
|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]] |
|- | |- | ||
|7 | |7 | ||
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs | |Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs | ||
| − | |3.1.3 | + | |[[3.1.3 Data security]] |
|- | |- | ||
|8 | |8 | ||
|Reported research outcomes must be traceable to experimental data | |Reported research outcomes must be traceable to experimental data | ||
| − | |3.1.2.1 | + | |[[3.1.2.1 Traceability of data and any person having impact on data]] |
|- | |- | ||
|9 | |9 | ||
| Line 47: | Line 47: | ||
|10 | |10 | ||
|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]] |
|- | |- | ||
|11 | |11 | ||
|All personnel involved in research must have adequate training and competence to perform assigned tasks | |All personnel involved in research must have adequate training and competence to perform assigned tasks | ||
| − | |3.2.1 | + | |[[3.2.1 General guidance on training]] |
|- | |- | ||
|12 | |12 | ||
|Protocols for experimental methods must be available | |Protocols for experimental methods must be available | ||
| − | |3.5.2 | + | |[[3.5.2 Protocols for methods and assays]] |
|- | |- | ||
|13 | |13 | ||
|Adequate handling and storage of samples and materials must be ensured | |Adequate handling and storage of samples and materials must be ensured | ||
| − | |3.3.3 | + | |[[3.3.3 Management of research materials and reagents]] |
|- | |- | ||
|14 | |14 | ||
|Research equipment and tools must be suitable for intended use and ensure data integrity | |Research equipment and tools must be suitable for intended use and ensure data integrity | ||
| − | |3.3.2 | + | |[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use]] |
|- | |- | ||
|rowspan="3"|'''Continuous performance''' | |rowspan="3"|'''Continuous performance''' | ||
|15 | |15 | ||
|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 | + | |[[4.1.1 Risk assessment]] |
|- | |- | ||
|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 | + | |[[4.2.2 Error and incident management]] |
|- | |- | ||
|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 | + | |[[4.1.2 Self assessment]] |
|- | |- | ||
|'''Sustainability''' | |'''Sustainability''' | ||
|18 | |18 | ||
|Resources for sustaining the EQIPD Quality System must be available | |Resources for sustaining the EQIPD Quality System must be available | ||
| − | |1.5. | + | |[[1.5.5 Sustainability]] |
|} | |} | ||
Back to the [[EQIPD Quality System]]. | Back to the [[EQIPD Quality System]]. | ||
Revision as of 07:56, 4 September 2020
| Categories | No | Item | 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 | |
| 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 |
Back to the EQIPD Quality System.
