Bioequivalence and Bioavailability Forum

Dear ElMaestro,

❝ If accountability is wrong after the trial and the person doing it has not received training then I have every reason to believe the authorities will butcher you for not having trained her/him. The root cause or at least a very good part of it will land exactly thereabouts.

Yes, for sure. But there, I would make a difference between training on a specific task and protocol training. I would expect the trial site to have some SOPs covering all activities relating to IMP (receipt, storage, dispensing, accountability etc.). Any person involved in these tasks should be trained on these SOPs, and should not be delegated any of these tasks unless appropriately trained.

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.

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.