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Thread: Courses on Sponsor Oversight File

  1. #1

    Courses on Sponsor Oversight File


    Would anyone know if there are any courses available on what should be kept in the Sponsor oversight file (SOF)? We have recently struggled as seemed to duplicate documents between the SOF and the TMF and wondered if there was specific guidance anywhere that someone could point me towards please? or if anyone knew of any training/courses available for this?

    Thank you

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Surely the SOF (although this is not a known or recognised acronym) is part of the TMF! If you look at the EMA "Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials" 31 March 2017 EMA/15975/2016. In many places (including the EU Clinical Trial Regulation) it states that the TMF contains all the information to be able to explain and reconstruct what happened in the trial.
    You might find the following useful. there is some information on oversight on the RQA webcast on ICH E6 R2 (www.theRQA) and the webcast on the EU Clinical Trial Regulation.. Also the MHRA GCP Guide (2012) has a lots about oversight.

  3. #3
    Absolutely..... evidence of sponsor oversight should be maintained in the trial master file. Where study responsibilities are outsourced, part of the TMF may be established and maintained by the CRO (and possibly in a different system to the sponsor's documents) but the sponsor still has a responsibility to maintain a TMF for those documents that they are responsible for. I really do not like the term "Sponsor Oversight File" because it gives the impression that this is not part of the TMF (similar actually to the 'Investigator Site File'.... which is also part of the TMF!).

    The TMF Reference Model provides some guidance regarding what type of documentation may be kept by the sponsor as evidence of oversight. However, each sponsor needs to make this determination for itself at the start of the study. There needs to be an oversight plan and so this plan will identify what documentary evidence should be created and maintained (per MHRA GCP Guide).

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