Good Clinical Practice Guide
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Thread: Query regarding Eligibiilty Confirmation

  1. #1

    Query regarding Eligibiilty Confirmation

    Our understanding is that only a medically qualified individual can confirm eligibility for a CTIMP and we understand medically qualified to be a professional registered with the GMC. However we were told today by a Sponsor of an Academically Sponsored CTIMP (Phase 3 using a licenced IMP off licence) that it was permitted for nurses to confirm eligibility on their trial. Just want to see how others feel about this and if this is something they would support?

  2. #2
    Forum Member
    Join Date
    Nov 2011
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    It probably depends upon which country the trial is in. The EU Clinical Trial Regulation states. that each Member State must determine who can be responsible for conducting trials at investigator sites (medic or non medic) and who can gain consent.

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