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

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  1. 5th May 2019, 07:11 PM #1
    RPR Consulting
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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.
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  2. 14th Jun 2019, 07:46 PM #2
    a123456
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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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