A New Article on FDA Clinical Trials

A new article published in the current issue of GxP Lifeline, a Master Control newsletter, explains the importance of final reports by clinical investigators. An often ignored regulatory requirement is that there should be a final report by the researcher to the sponsor of the clinical trial. The author of the article, yours truly, explains that final reports are not just another thing to do to satisfy FDA regulations, but a tool to help prepare for FDA bioresearch monitoring inspections. You can read for yourself on the page above entitled Carl’s Articles on FDA Stuff

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2 Responses to A New Article on FDA Clinical Trials

  1. Michael Forster says:

    I work in the pharmaceutical industry and I’m curious to know whether the FDA is leading the way in terms of the requirements of the Trial Master File, or whether there are other countries that have different or more strict requirements. Do you know whether any emerging markets are moving in that direction, or whether they mostly follow the lead of the FDA, EMEA, and MHRA? Do you have any suggestions for where to find this kind of information? Thank you.

    • Carl's Blog on FDA Stuff says:

      My personal opinion is that FDA does not directly regulate a Trial Master File (TMF) as required clinical trial documentation. The expression, “TMF” is taken out of the introduction to Section 8, Essential Documents, of the International Conference on Harmonization GCP Guidance Document E6 (see E6: Section 8.1). When I was at FDA, auditing the TMF was not part of the Bioresearch Monitoring inspectional training (that might have changed). Inspectors reviewed and collected documents listed in the Compliance Program Guidance Manuals that you can find on the FDA GCP webpage under “Bioresearch Monitoring.” As such, the entire concept of a TMF seems to be coming from the ICH countries, particularly in Europe.

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