Difference between revisions of "Core Requirements"
| Line 64: | Line 64: | ||
|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 General guidance on training]] | |[[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 Protocols for methods and assays]] | |[[3.5.2 Protocols for methods and assays]] | ||
| − | |No specific document needed except the protocols | + | |No specific document, |
| + | needed except the protocols | ||
|- | |- | ||
|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 Management of research materials and reagents]] | |[[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 Processes to enable computerized and non-computerized systems being suitable for intended use]] | |[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use]] | ||
| − | | | + | | - |
|- | |- | ||
|rowspan="3"|'''Continuous performance''' | |rowspan="3"|'''Continuous performance''' | ||
| Line 90: | Line 91: | ||
|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]] | ||
| − | |No specific document needed, but errors should be documented with the experimental protocol | + | |No specific document needed, |
| + | but errors should be documented with the experimental protocol | ||
|- | |- | ||
|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 Self assessment]] | |[[4.1.2 Self assessment]] | ||
| − | |Template Self assessment available | + | |Template: |
| + | Self assessment available | ||
|- | |- | ||
|'''Sustainability''' | |'''Sustainability''' | ||
| Line 101: | Line 104: | ||
|Resources for sustaining the EQIPD Quality System must be available | |Resources for sustaining the EQIPD Quality System must be available | ||
|[[1.5.5 Sustainability]] | |[[1.5.5 Sustainability]] | ||
| − | | | + | | - |
|} | |} | ||
Back to the [[EQIPD Quality System]]. | Back to the [[EQIPD Quality System]]. | ||
Revision as of 18:46, 26 November 2020
| Categories | No | Core Requirement | Toolbox reference | Documents required |
| 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 | Template | |
| Quality culture | 3 | The research unit must have defined quality objectives | 1.1 Mission | Template |
| 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 | Template |
| 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 | Template | |
| 8 | Reported research outcomes must be traceable to experimental data | 3.1.2.1 Traceability of data and any person having impact on data | Template | |
| 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 | No specific document needed,
but document in Study plan |
| 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 | No specific document,
needed except the protocols | |
| 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 | To be documented with experimental protocol or a risk assessment protocol if performed |
| 16 | Critical incidents and errors during study conduct must be analyzed and appropriately managed | 4.2.2 Error and incident management | No specific document needed,
but errors should be documented with the experimental protocol | |
| 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 | Template:
Self assessment available | |
| Sustainability | 18 | Resources for sustaining the EQIPD Quality System must be available | 1.5.5 Sustainability | - |
Back to the EQIPD Quality System.
