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  • in reply to: Where do I file a Protocol Deviation Guideline? #4717

    Thank you everyone and I am so sorry for my late reply. I have been so busy, I forgot I posted the question. I do think it might be best filed in artifact 01.04.02 as it is a guideline for all of our studies to inform CRAs how to enter PDs in our CTMS. It is not a report or a listing of actual PDs.

    in reply to: Where do I file a Protocol Deviation Guideline? #4562

    Hi Eldin,

    Excellent question — it is not a trial specific guideline but used across all of our programs. Should it not be filed in the TMF or should it be filed in our TMF for each study?

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