Core Requirements

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Categories​​​	No	Item	​Toolbox item
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 ​|-	Quality culture ​ ​ 3 The research unit must have defined quality objectives ​1.1 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​ ​ ​ ​​Data integrity ​ ​ ​ 6 Generation, handling and changes to data records must be documented ​2.3.1​ 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 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 11 All personnel involved in research must have adequate training and competence to perform assigned tasks ​3.2.1 12 Protocols for experimental methods must be available ​3.5.2 13 Adequate handling and storage of samples and materials must be ensured ​3.3.3 14 Research equipment and tools must be suitable for intended use and ensure data integrity ​3.3.2​ ​ ​ ​Continuous performance ​ ​ 15 Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data 4.1.1​​ 16 Critical incidents and errors during study conduct must be analyzed and appropriately managed ​4.2.2 17 An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​ ​4.1.2 ​ ​ Sustainability 18 Resources for sustaining the EQIPD Quality System must be available ​1.5.5​​

Back to the EQIPD Framework​.​​​​