3.5.1 Animal and non-animal method and assay qualification
A. Background & Definitions
Research methods utilized must be demonstrated to be 'fit for purpose'.
B. Guidance & Expectations
Prior to use:
- There must be a procedure for the qualification of research methods as 'fit for purpose'. This includes non-standard methods and laboratory-developed methods.
- Any modifications of qualified research methods or use outside their intended scope should be made transparant and additional qualification should be conducted as needed.
- Records of the qualification should be retained (incl. used validation procedure, specification of requirements, results obtained, statement of the fitness for intended use).
- Method robustness should be monitored, through variation of controlled parameters, comparison of results achieved with other validated methods and/or interlaboratory comparison.
- Users performing assays must be qualified, trained and have access to written instructions on the assay.
- The qualified method used as well as any deviations from the qualified method must be documented in the experimental record with impact asessment.
- It may be helpfull to have a repository of methods and assays with version control so that the method and version used can be referenced in the study data.
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