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Thread: protocol Deviations due to visits -- how to prevent

  1. #1

    protocol Deviations due to visits -- how to prevent

    Do you have an example of a statement in a protocol that allowed variations to visit windows and thus out of window visits (not on the scheduled day) were not deemed protocol deviations. Currently, a statement to this effect is not in the protocol and the PI does not want to have a window of say 3 days, but it is a logistical nightmare regarding data management and monitoring reports.
    Last edited by MHRA Moderator; 2nd Mar 2016 at 11:10 AM. Reason: Removal of duplicate text

  2. #2
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    The protocol needs to be followed otherwise, by definition, there is a protocol deviation. If you need longer windows then this should be included in an amendment.
    Whether of not the subsequent protocol deviations are deemed to be "significant" from a subject welfare or data integrity perspective should then be determined by the project team, including the Medical Monitor, Clinical Scientist and Statistician.

  3. #3
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    ICH has an excellent document ICH E3
    EMA/CHMP/ICH/435606/2012
    Committee for medicinal products human use (CHMP)
    ICH guideline E3 - questions and answers (R1)
    Step 5. July 2012

    Q; What is the distinction between a protocol deviation, important protocol deviation, and a protocol violation?

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