Difference between revisions of "Documentation in EQIPD"

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=UNDER CONSTRUCTION=
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Revision as of 17:41, 30 November 2020

UNDER CONSTRUCTION

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 Must be documented with 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 -
8 Reported research outcomes must be traceable to experimental data 3.1.2.1 Must be documented 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 - -
​​​Research processes 10 Investigator must declare in advance whether a study is intended to inform a formal knowledge claim 2.1.4 - Must 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 - Participation in training must be documented with the training records
12 Protocols for experimental methods must be available 3.5.2 - All procedures used in experiments must be documented in the protocol (template)
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, 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​​ - Study/experimental protocols must have a risk assessment section, see 2.1.1 Study (experimental) plan or to be documented in a Risk assessment template
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 or in a separate Error reporting document
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 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​.​​​​