Bioequivalence and Bioavailability Forum

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