Good Clinical Practice Guide
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Thread: Should people carrying out their normal clinical role be added to Delegation Log

  1. #1
    Forum Member
    Join Date
    Oct 2018

    Should people carrying out their normal clinical role be added to Delegation Log

    We are being delayed in our start up as a site for a ctimp where the Sponsor requires a signature on a delegation log from "anyone" the XRay department.
    There will not be one individual delegated any research specific tasks. All staff will be carrying out their normal NHS roles.
    The Sponsor agrees that an individual is not being delegated any tasks, that no one requires training, and that they do not want training records or CVs.
    No individual from the department is willing to sign on behalf of the department as they do not sign delegation logs for any other studies that require the XRay results from normal care.
    We are at stalemate.
    Anyone help?

  2. #2
    Forum Member
    Join Date
    Nov 2011
    I donít think I understand.
    (ICH E6 4.1.5 and RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 3.2.24 footnote 9) It is the Investigator (or if a team is involved, the Principle Investigator) who has to maintain a list of those delegated significant trail related duties!
    The I/PIs are required to perform all tasks themselves, unless they delegate tasks (& document PI oversight) to appropriate team personnel, who are documented as being qualified by education, training and experience, to carry out those tasks. Surely only the PI can approve the delegation of a trial related task?

    Not to be confused with (ICH E6 8.3.24) the signature log used to document signatures and initials of all persons authorised to make entries and/or corrections on CRFs. Obviously (8.1) it is acceptable to combine documents provide that the individual elements are readily identifiable.

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