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Thread: New PI delegation

  1. #1
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    New PI delegation

    When a new PI takes over what documentation is necessary to cover the delegation of tasks that the previous PI has assigned? Since the incoming PI will not have reviewed training/experience and delegated tasks to those individuals currently on the log (and may not even know who individuals on the log are). Does a new delegation log need to be completed or can a file note be completed to confirm on-going delegation to all tasks previously assigned by the previous PI continues under the new PI?

  2. #2
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    I donít think I understand.
    The purpose of the PIs delegation of trial related duties log, is to document the delegation by the PI of significant trial related duties to appropriate team personnel, who are documented as being qualified by education, training and experience, to carry out those tasks (ICH E6 4.1.5 and EMA Volume 10 chapter 5, RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 3.2.24 footnote 9).
    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.
    How can a PI delegate tasks to individuals they do not even know? I would have thought that it behoves the PI to at least look into the education and training of the individuals and also whether they have ever had tasks rescinded/withdrawn from them. Just an idea.
    Make sure that the PI not only prospectively and contemporaneously approves properly qualified and TRAINED team members, but also rescind/withdraw that delegation if personnel are non-compliant or are no longer performing that task. It is often found that personnel are delegated a task, but never have that duty withdrawn from them even when they are no longer working on the trial.
    As a general rule Ė do not use notes to file when other properly constituted documents could be used.

    Documented oversight of all trial personnel and tasks is vitally important (see ICH E 6 R2).

    There are interesting Q & As on all these topics (including Note to File) on the RQA website (www.theRQA.com)

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