Good Clinical Practice Guide
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Thread: Consent form versions

  1. #1
    Forum Member
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    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.

  3. #3
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    Nov 2011
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    Sounds like a business decision to me. There is no specific requirement to have this information in the eCRF. You are right that it is better to have it electronically. Also this will help you with management and GCP required oversight of sites. It will be part of your Risk Based Monitoring to have Central Monitoring using data such as this. So a good idea, but up to you how you capture it.

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