Documentation in EQIPD

From EQIPD
Revision as of 13:05, 2 December 2020 by Bjoerngerlach (talk | contribs)
Jump to: navigation, search



UNDER CONSTRUCTION

not finalised yet

Categories​​​ No Core Requirement Toolbox reference Documentation of the Core Requirements
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 organisation and communication plan 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 these mission.
4 All activities must comply with relevant legislation and policies 1.4.2 No These documents usually must be available for legal purposes and are usually stored at t dedicated space in the research unit or could be hold available in the Dossier.
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 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 different 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

*The provided templates are suggestions which may be used. However, their use is not a requirement, the requirement is the documentation and description associated with the Core Requirement which can have any format suitable for the research unit.

Back to the EQIPD Quality System​.​​​​