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Thread: Electronic signatures - which type are acceptable?

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  1. #1
    Forum Member
    Join Date
    Nov 2016
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    43
    Have you looked at mhra data integrity guidance for gxp
    so fda have guidance

  2. #2
    Dear Eldin, unfortunately I cannot contribute to your question. Currently we are using electronic workflows in our Document Management System for the protocol collecting the agreement of the contributing experts. But thereafter we still have a paper signature page for a few selected signatories (the statistician, the sponsor's medically responsible person, the coordinating investigator) - so no reason for refusal by authorities or ethics committees within the scope of your example. However, we may move forward to a completely e-signed protocol. Therefore the topic is very interesting.

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