Compliance with FDA requirements on annual reports

One of the most overlooked requirements by FDA is for the clinical investigator to complete a final report to the sponsor after the completion of a clinical trial. I think that having a short final report helps a clinical investigator in preparing for an FDA inspection. After all, some inspections take place Years after the study is complete. You can find the requirement in 21 CFR 312.64 where it says:

(c) Final report. An investigator shall provide the sponsor with an adequate report shortly after completion of the investigator’s participation in the investigation.

I am offering a humble contribution to this issue in the following document. It is NOT an FDA document but everything in it was taken from different parts of the FDA website.


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