Good Clinical Practice Guide
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Thread: PI signature on Delegation of authority log

  1. #1
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    PI signature on Delegation of authority log

    According to the MHRA GCP Gray guide the delegation ofauthority needs to be signed by PI prior to the clinical trial activity being undertakenby the individual e.g. sub investigator, site staff member
    In a unit where they rely on lot of contingency /bank staffwhere some of whom work infrequently and sometimes they sign the delegation logand the protocol training log only just ahead of their shift at the unit (outof normal working hours evenings, weekends) and the PI then countersigns assoon as possible afterwards (according to GCP guidance).
    Hence a couple of questions for the forum for discussion:
    What, wouldbe the reasonable time-frame in which the PI should counter-sign the delegationof authority log?

    • If a PIs on annual leave; Is, it reasonable forPI to sign the delegation log to be done immediately before and immediatelyafter a period of annual leave?

    Is itacceptable for the PI to counter-sign the delegation of authority + Site staffsignature log ahead pre-emptively for sub- investigators/other site staff on apreconditional basis that they will complete their protocol training log afterwards?

  2. #2
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    There are lots of replies to similar questions on this forum about PI delegation & delegation logs.

    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. The PI will not know that the individuals have been suitably trained, if there is no documented evidence of that training having been completed before the task is delegated to them.

    Your Risk Assessment could detail when staff are conducting routine activities that they are already trained and qualified for and because they are not performing a specific trial related task, hence they may not need trial related training. The MHRA GCP guide (2012) discussed about using a risk proportionate approach to training needs.

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