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'.

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).

During 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.

tba

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