Good Clinical Practice Guide
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Thread: Are signatures on curriculum vitae (CV) required?

  1. #1
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    Aug 2015
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    Are signatures on curriculum vitae (CV) required?

    Hi All,

    Is it documented any where that CVs require signature? GCP does not request signatures specifically as far as I've known, so where has this standard procedure developed from or referenced in guidence?

    Any ideas or suggestions as to if Signatures are required would be appriciated. This is for the Investigators as well as ancillary staff like Nurses.

    Thank you

  2. #2
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    Nov 2011
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    The MHRA GCP Guide (2012) 14.2 Quality Systems states:-
    “..demonstrate that training has occurred, documentation must2 be maintained and retained for all staff ….. The extent and content of this documentation is a business decision, but typically includes:
    • a current job description dated and signed by the post-holder and their line manager to demonstrate the date on which current roles and responsibilities have been agreed
    • a curriculum vitae to demonstrate current and previous relevant education and experience, signed and dated to confirm the date of the document and ownership by the named individual
    • confirmation that GCP training has taken place (including clear reference to the framework used in the training, such as, Statutory Instruments, EU Directives)
    • role-specific training relevant to the post-holder’s duties &trial role(s)
    • written procedure training records”

    The word “Typically” is not a MHRA codified word, such as "must" and "should". It may mean that it is good practice?


    Reference:- Must2 = Reg31A.(4) The essential documents relating to a clinical trial are those which—(a) enable both the conduct of the clinical trial and the quality of the data produced to be evaluated

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