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?