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Thread: Paper DCF Sign-Off

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  1. #1
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    Question Paper DCF Sign-Off

    A bit old skool but just after a consensus on the interpretation of what constitutes investigator endorsement of changes to the database after submission of signed paper CRFs. These changes would be made via paper DCFs and could be signed by an investigator or other (non-medic) staff depending on delegation and the type of query.

    Is investigator delegation enough to consider changes authorised/endorsed or would a final investigator signature be required in addition? Wording in the Grey Guide could be interpreted either way in my opinion.

  2. #2
    You may want to consult ICH E6(R2), section 4.9.3 directly:
    "...Sponsors should provide guidance to investigators and/or the investigator's designated representatives on making such corrections...."
    In combination with´8.3.14 ("To document that the investigator or authorized member of the investigator's staff confirms the observations recorded") and 8.3.15, I assume a (documented) delegation to a adequately qualified and trained individual is acceptable for signing data correction forms.

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