Good Clinical Practice Guide
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Thread: Sub/Co-Investigator absence and delegation of authority

  1. #1
    Forum Member
    Join Date
    Feb 2018

    Sub/Co-Investigator absence and delegation of authority


    Should a sub-I on maternity leave be taken off the DOA until her return or no update is required as the same essential tasks will be assigned to her once back to work.


  2. #2
    Forum Member
    Join Date
    Nov 2011
    There are some good discussions about this on this very forum

    There are lots of replies to similar questions on this forum about PI delegation & delegation logs. And of course the MHRA GCP Guide 2012 has excellent advice.

    My understanding is that the PI takes total responsibility for the trial at an investigator site. That is, he or she must perform all the protocol and GCP required tasks, unless the PI formally and proactively delegates some of those tasks to appropriately qualified, trained and experienced named staff. The PI, at all times, retains the overall responsibility for the trial and must supervise those individuals that he or she delegates. The PI should not allow staff who have not been delegated trial related tasks, to perform those tasks before they have been formally delegated. Also to 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 It is often found that personnel are delegated a task, but never have that duty withdrawn from them even when they are no longer working on the trial. Hence when a delegate is absent for sometime the delegation log should reflect when they have ceased trail duties and when they have restarted. It is also important to document whether the individual received re-training after an absence.

    Its all about documenting competency of the delegates to perform GCP duties. While they are absent they will not be able to perform those duties and when they return we can not automatically assume that they are still competent. No only will there be updates about the trial, there may be updates about GCP and/or SOPs; and refresher training on the same tasks to ensure that they are still competent. Probably a documented risk proportionate approach might be best. If the absence was short and the person was not performing critical trial related duties (perhaps only performing duties, in a clinical trial situation, but that were very similar to normal clinical practise) then the risks would be very low. If the person was performing critical tasks such as eligibility assessments; efficacy outcome measures; safety assessments ; etc etc then the risks would be high and there would be a need for documented mitigation measures.

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