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Thread: Patient consented but not randomized - paperwork

  1. #1
    Forum Member
    Join Date
    Jun 2016

    Patient consented but not randomized - paperwork


    We have several patients who have consented but subsequently did not get randomized and hence enter the trial. What shall we do with their paperwork? Consent forms etc?

    Many thanks

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Keep them in the TMF and noted in the subjects notes that they consented to the trial. The subjects did consent to be in the trial and hence are part of the trial. The MHRA might inspect the trial and will ask to see all records of those who consented. Subjects consent not only to be in the trial, but also to you retaining their trial related documentation and to direct access to those documents by monitors, auditors and inspectors. You may have also done some pre-screening and screening on these subjects and this should also be retained for the full period required by UK law if your trial is in the UK. Buy a copy of the MHRA GCP Guide (2012)

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