Good Clinical Practice Guide
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Thread: Consent form versions

  1. #1
    Forum Member
    Join Date
    Sep 2019
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    Consent form versions

    Hello, we are developing an e-crf and I wanted to capture informed consent form versions and dates. I'm having kick back from IT as they say this is available on the consent form log. I think we should have this info electronically but is there a requirement to have this information as part of the e-crf?

    Thanks

  2. #2
    Its beneficial to validate assessment dates against consent, given that generally most trial events should occur post consent.

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