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.

Dear Ratnakar
You have to differentiate between functions and names (of individual staff members). For example if the PI delegates blood drawing to study nurses he/she does not have to name the individual person as long as there is a detailed job description explaining the study nurse's tasks and responsibilities.
I hope this helps
Kind regards
Dr_Dan

Dear Ohlbe

❝ Your system would require to have the PI sign the job description of each individual, to show that he agrees with its contents and considers the person as appropriately qualified for that job.

I slightly disagree. IMHO there is no need for the PI to sign the job description of each individual if there is a clear definition what needs to be fulfilled to be appropriately qualified for that job (e.g. study nurse)

❝ maintain a list of individuals with a specific job title (e.g. study nurse). A copy should be put in the TMF;

I agree. I would expect this list to be combined with the signature log of the respective study.

❝ ensure (and document) that each protocol does not require any specific skills not covered by the "normal" job description.

I agree. In my considerations I assumed that in a big CRO the PI would not do the human ressource planning.

Kind regards
Dr_Dan