Bioequivalence and Bioavailability Forum

Dear Forum Members,
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?”
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?
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?
Your views are highly appreciated.

Thanking you in advance,
Ratnakar

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Edit: Category changed and thread linked. [Helmut]