Difference between revisions of "Documentation in EQIPD"
| Line 37: | Line 37: | ||
|[[4.2.3 Responsible conduct of research|4.2.3]] | |[[4.2.3 Responsible conduct of research|4.2.3]] | ||
| - | | - | ||
| − | | | + | |It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available |
|- | |- | ||
|rowspan="4"|'''Data integrity''' | |rowspan="4"|'''Data integrity''' | ||
| Line 44: | Line 44: | ||
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]] | |[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]] | ||
|rowspan="3"|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] | |rowspan="3"|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] | ||
| − | | | + | |Documented with the experimental/study protocol |
|- | |- | ||
|7 | |7 | ||
| Line 54: | Line 54: | ||
|Reported research outcomes must be traceable to experimental data | |Reported research outcomes must be traceable to experimental data | ||
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]] | |[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]] | ||
| − | | | + | |This requires detailed documentation within the study plan, e.g. an unique study ID |
|- | |- | ||
|9 | |9 | ||
| Line 67: | Line 67: | ||
|[[2.1.4 Purpose of research|2.1.4]] | |[[2.1.4 Purpose of research|2.1.4]] | ||
| - | | - | ||
| − | | | + | |To be documented in the study/experimental protocol |
|- | |- | ||
|11 | |11 | ||
| Line 73: | Line 73: | ||
|[[3.2.1 General guidance on training|3.2.1]] | |[[3.2.1 General guidance on training|3.2.1]] | ||
| - | | - | ||
| − | | | + | |Participation in training must be documented with the training records |
|- | |- | ||
|12 | |12 | ||
| Line 79: | Line 79: | ||
|[[3.5.2 Protocols for methods and assays|3.5.2]] | |[[3.5.2 Protocols for methods and assays|3.5.2]] | ||
| - | | - | ||
| − | | | + | |All experimental protocols used in experiments must be documented |
|- | |- | ||
|13 | |13 | ||
| Line 85: | Line 85: | ||
|[[3.3.3 Management of research materials and reagents|3.3.3]] | |[[3.3.3 Management of research materials and reagents|3.3.3]] | ||
| - | | - | ||
| + | |This information must be available, e.g. as chemical data sheets or within study/experimental protocol | ||
|- | |- | ||
|14 | |14 | ||
| Line 90: | Line 91: | ||
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]] | |[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]] | ||
| - | | - | ||
| + | |Study/experimental protocols must show that equipment was fit-for-purpose | ||
|- | |- | ||
|rowspan="3"|'''Continuous performance''' | |rowspan="3"|'''Continuous performance''' | ||
| Line 96: | Line 98: | ||
|[[4.1.1 Risk assessment|4.1.1]] | |[[4.1.1 Risk assessment|4.1.1]] | ||
| - | | - | ||
| − | | | + | |Study/experimental protocols must have a risk of bias section, see [[2.1.1 Study plan]] |
|- | |- | ||
|16 | |16 | ||
| Line 102: | Line 104: | ||
|[[4.2.2 Error and incident management|4.2.2]] | |[[4.2.2 Error and incident management|4.2.2]] | ||
| - | | - | ||
| − | | | + | |Critical incidents and errors must be documented with the experimental protocol |
|- | |- | ||
|17 | |17 | ||
Revision as of 13:13, 30 November 2020
| 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 | - | It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available | |
| Data integrity | 6 | Generation, handling and changes to data records must be documented | 2.3.1 | Documentation plan | Documented with the experimental/study protocol |
| 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 | This requires detailed documentation within the study plan, e.g. an unique study ID | ||
| 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 | - | To be documented in the study/experimental protocol |
| 11 | All personnel involved in research must have adequate training and competence to perform assigned tasks | 3.2.1 | - | Participation in training must be documented with the training records | |
| 12 | Protocols for experimental methods must be available | 3.5.2 | - | All experimental protocols used in experiments must be documented | |
| 13 | Adequate handling and storage of samples and materials must be ensured | 3.3.3 | - | This information must be available, e.g. as chemical data sheets or within study/experimental protocol | |
| 14 | Research equipment and tools must be suitable for intended use and ensure data integrity | 3.3.2 | - | Study/experimental protocols must show that equipment was fit-for-purpose | |
| Continuous performance | 15 | Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data | 4.1.1 | - | Study/experimental protocols must have a risk of bias section, see 2.1.1 Study plan |
| 16 | Critical incidents and errors during study conduct must be analyzed and appropriately managed | 4.2.2 | - | Critical incidents and errors must 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 | - | |
| 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.
