Documentation in EQIPD
Revision as of 16:48, 9 February 2021 by Anton.bespalov (talk | contribs)
EQIPD Quality System is lean and does not require excessive documentation.
The following table describes the documentation required to address the EQIPD core requirements.
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.
| Categories | No | Core Requirement | Toolbox reference | Stand-alone document | Expected documentation | Research team | 1 | Process owner must be identified for the Quality System | 1.5.2.3 | No | No documentation needed, verbal agreement sufficient | ||
| 2 | Communication process must be in place | 1.2 | Yes | A brief overview of the organisational structure and the communication lines could be documented in the Communication plan template | |||||||||
| Quality culture | 3 | The research unit must have defined quality objectives | 1.1 | Yes | The Mission statement template could be used to document quality goals of a research unit | ||||||||
| 4 | All activities must comply with relevant legislation and policies | 1.4.2 | No | These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format | |||||||||
| 5 | The research unit must have a procedure to act upon concerns of potential misconduct | 4.2.3 | No | 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 | Yes | Could be documented in the Documentation plan and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent | ||||||||
| 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 | Could be documented in the Documentation plan | ||||||||||
| 8 | Reported research outcomes must be traceable to experimental data | 3.1.2.1 | Could be documented in the Documentation plan and additional information should be available within the study plan and along the data usage chain, 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 | No | This information could for example be found in presentation as reference to the original experiments | |||||||||
| Research processes | 10 | Investigator must declare in advance whether a study is intended to inform a formal knowledge claim | 2.1.4 | No | This information could be documented in the study/experimental protocol, see 2.1.1 Study (experimental) plan | ||||||||
| 11 | All personnel involved in research must have adequate training and competence to perform assigned tasks | 3.2.1 | No | Participation in training could be hold available with the training records | |||||||||
| 12 | Protocols for experimental methods must be available | 3.5.2 | No | All procedures used in experiments could be hold available in the study/experimental protocol (template) | |||||||||
| 13 | Adequate handling and storage of samples and materials must be ensured | 3.3.3 | No | This information could be hold 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 | No | Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances | |||||||||
| Continuous performance | 15 | Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data | 4.1.1 | No | Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see 2.1.1 Study (experimental) plan and for a risk assessment on the level of the research unit, it could be documented in the Risk assessment template | ||||||||
| 16 | Critical incidents and errors during study conduct must be analyzed and appropriately managed | 4.2.2 | No | Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate Error reporting document for the research unit level | |||||||||
| 17 | An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues | 4.1.2 | Yes | This could be documented in the Self assessment template | |||||||||
| Sustainability | 18 | Resources for sustaining the EQIPD Quality System must be available | 1.5.5 | No | No documentation needed | ||||||||
Back to the EQIPD Quality System or Core Requirements.
