Bioequivalence and Bioavailability Forum

Hi Ratnakar,

Not quite sure I understand the background for your asking, but here's my take:

❝ Recently during one of the sponsor’s audit, sponsor pointed out that Delegation of responsibilities to a study staff is a core responsibility of a PI and it cannot be delegated to a sub investigator with the reference to the Delegation of PI duties at MHRA GCP Forum, “PI delegating PI duties?”

Use the term duty rather than responsibility (responbilities in a trial are fixed by contract and regulations; only the duties are delegated).

❝ I was just wondering how is it possible for a PI to delegate duties to all the staff in the situation where PI is on leave or not available at Site (early or late night hrs? Which leads to the following questions in mind, Can delegation be done separately before protocol training by PI and protocol training and acceptance of the responsibility is done by the respective staff after attending the protocol training from sub investigator?

Rules and rules. Sometimes PIs are de facto not very often in the facility where the studies are run. In such cases it is even a good idea that they delegate as many tasks as possible incl. protocol training. Delegations do not have to be done all at the same time. It would be ok if the PI first delegates the task of study training to a sub-inv. I think, technically, a subinvestigator could also be assigned the task of delegating the rest of the tasks from the PI, if that's what you ask, but from the top of my head I have not seen this happening in practice. The latter sounds rather theoretical, though. If the PI is such a rare guest that she/he cannot find time to sign a delegation sheet then perhaps the whole matter is the organisation and not the regulation?

❝ Also can sub investigator initiate a new study in the absence of PI (if PI is on long leave), right from delegation and protocol training?

As above, yes. Sub/co-inv. can do anything except sign for the PI. If your question relates to BE / single centers then bear in mind that in multicenter trials this is more or less what goes on on a regular basis in various colours and flavours.