## Protocol training or job training ? [Study Per­for­mance]

Hello Ohlbe,

» Now you receive a new trial with a nice protocol. The question would be, will the routine SOPs apply to that particular trial (in which case no additional training is required), or are there specificities that need to be addressed ? So each protocol needs to be read, understood and assessed, and any staff involved from there on should be informed.

Yes, there are two types of training. General training (you might say, the training that the job description merits, such as overarching IMP handling SOPs) and the study-specific training (presence or absence of any overriding IMP handling instructions in the protocol etc; this is the training that the clauses you refer to in ICH E6 relate most directly to).

» The question then becomes, who should do it ? My concern is that the PI may not be the most qualified person to do it. There are chances that the pharmacist himself may actually be more qualified than the PI… In any case, the PI remains responsible for ensuring that there is such a system in place, and that the job is done.

That is true, the pharmacist knows more about IMP handling than the PI. And the same for phlebotomists, statisticians etc. The PI knows how to be a PI (presumably or hopefully ).
"No man is an island". Training to me is not just about the person's individual own functions, but also an orientation that helps make the execution smooth, ethical and safe. It is generally appropriate that the overall responsibility rests with a single person even if she/he is not the most competent person to do each individual task. Training is a two-way street. Perhaps the last trial the CRO did on topical creams had an accountability issue so the next time such a formulation comes up the pharmacists suggests the PI to remind the dosing team of it, or to emphasize the signs of wrong IMP dosing on the subjects. The team generally benefits from being training together so that staff know who is on the team and who is not in case of irregularities. And so forth.

I am not a regulator so this is a personal view. I am also aware that theory and practice are sometimes different things.

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Best regards,
ElMaestro