as a general rule we don’t need to use local labs at each investigator site for our studies, we have our company lab that handles the necessary testing. However, we do occasionally have studies which require standard blood tests to be done for all participants and the results are recorded in the CRF. Obviously, we need to have all the applicable lab accrediations/certifications, CV, normal ranges etc. in the ISF – but do we need also to have copies in the sponsor TMF? The Ref Model indicates yes, but I wonder if it is sufficient to document in monitoring reports or elsewhere that the applicable lab docs are available and up to date in the ISF? What is the value added in having this information duplicated in the sponsor TMF? I can see the normal ranges being required because they might need to be included/referenced in the statistical analysis, but what about the other documentation?
We have included local lab information in the TMF at the site or country level – normal ranges, accreditation certificates, along with the central lab information at the study level.
I understand those who express concern about “duplicating” the ISF in the TMF but my understanding is that an inspector may not be satisfied with a note to file repeatedly pointing to the ISF – not sure there is a “correct” answer