Bioequivalence and Bioavailability Forum

Dear ElMaestro,

❝ Let me in this regard add that I know of experienced EU inspectors who consider the bioanalytical work to fall under GCP [...], while others don't see it that way.

Depends whether you ask the question in the UK or in France...

❝ It has some legal and practical implications how this is viewed, I believe. A further complicating aspect of this is that if a bioanalytical CRO falls within the scope of GCP then the PI must formally transfer the analytical duty via his delegation log and he may have a hell of a problem with some of the GCP clauses [...]

❝ that could easily be tricky if the investigator is in Ahmedabad and the bioanalytical work takes place in Toronto.

❝ E.g. if a P.I. can never give away any part of his responsibilities but only delegate some of the duties then it seems to me like OECD GLP and GCP are almost mutually exclusive because GLP hands out responsibility left and right.

I would not push it as far as you do. Remember the definition of the investigator in ICH E6: A person responsible for the conduct of the clinical trial at a trial site (emphasis added). The investigator is responsible for what happens at his site and what is done by his staff. Not for anything done by a clinical lab, the X-ray facility, etc.

That's quite different from GLP, where there is a single study director for the whole study, with principle investigators at other sites, and a multi-site organisation.

Regards
Ohlbe