Difference between revisions of "Core Requirements"

Jump to: navigation, search
m (Protected "Core Requirements" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite)))
(No difference)

Revision as of 07:57, 4 September 2020

Categories​​​ No Core Requirement Toolbox reference
Research team 1 Process owner must be identified for the Quality System Process owner
2 Communication process must be in place 1.2 Scope
Quality culture 3 The research unit must have defined quality objectives ​ 1.1 Mission
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
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 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
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
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​​
16 Critical incidents and errors during study conduct must be analyzed and appropriately managed 4.2.2 Error and incident management
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 Sustainability

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