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The same SOP Deviation ( Temp range) on multiple studies



  • Anon
    16/09/2019 09:49
    For the same SOP deviation (reporting process & already rectified) , that occurred on multiple studies ; - should each study have it's own SOP Deviation for the study master file? (It was not a study plan/Protocol Deviation) - can one General deviation be added for all applicable studies - explaining the deviation /impact & the actions already taken for the period/timeframe ? Thank You
  • anon
    16/09/2019 10:31
    I would have thought that this is up to your SOP on SOPs, and your SOP deviation procedure and SOP group. Document in your risk assessment
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