Good Clinical Practice Guide
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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 10:10 AM. Reason: Removal of duplicate text

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