Core Requirements

From
Revision as of 09:22, 2 December 2020 by Bjoerngerlach (talk | contribs)
Jump to: navigation, search
Categories​​​ No Core Requirement Toolbox reference EQIPD provided templates*
Research team 1 Process owner must be identified for the Quality System 1.5.2.3 Process owner -
2 Communication process must be in place 1.2 Scope Communication plan
Quality culture 3 The research unit must have defined quality objectives ​ 1.1 Mission Mission statement
4 All activities must comply with relevant legislation and policies 1.4.2 Adherence to legal and regulatory considerations -
5 The research unit must have a procedure to act upon concerns of potential misconduct 4.2.3 Responsible conduct of research -
​​Data integrity 6 Generation, handling and changes to data records must be documented 2.3.1 Generation, recording, handling and archiving of raw data Documentation plan
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 Data security
8 Reported research outcomes must be traceable to experimental data 3.1.2.1 Traceability of data and any person having impact on data​
9 Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​ 2.4 Reporting -
​​​Research processes 10 Investigator must declare in advance whether a study is intended to inform a formal knowledge claim 2.1.4 Purpose of research Study protocol
11 All personnel involved in research must have adequate training and competence to perform assigned tasks 3.2.1 General guidance on training -
12 Protocols for experimental methods must be available 3.5.2 Protocols for methods and assays Protocols for experimental methods
13 Adequate handling and storage of samples and materials must be ensured 3.3.3 Management of research materials and reagents -
14 Research equipment and tools must be suitable for intended use and ensure data integrity 3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use -
Continuous performance 15 Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data 4.1.1 Risk assessment​​ Study protocol and Risk assessment template
16 Critical incidents and errors during study conduct must be analyzed and appropriately managed 4.2.2 Error and incident management Error reporting template
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 Self assessment
Sustainability 18 Resources for sustaining the EQIPD Quality System must be available 1.5.5 Sustainability -

*The provided templates are suggestions which may be used. However, it is not mandatory to use the templates developed by EQIPD. It is up to the research unit to modify them, develop new or use existing documentation.


For information on required documentation within EQIPD please visit: Documentation in EQIPD

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