View source for 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).

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.


== C. Resources ==
to be added



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