Bioequivalence and Bioavailability Forum

Dear Dshah,

❝ […] shall sponsor monitor on going BA runs?

Up to you. It is neither made mandatory, nor forbidden by any guideline, as far as I know.

❝ ❝ make clear to the sponsor representatives in advance that they shall not try and influence in any way

❝ So shall CRO share their SOP and then sponsor shall make agenda?

The CRO should either make their SOPs available in advance (so that the monitor or auditor can prepare his visit) or at least make them available at the site during the visit. The monitor or auditor will decide what he wants to monitor or audit based on the sponsor's own SOPs and using his brain. But again, he should check compliance with regulations, guidelines and the lab's SOPs, but not interfere with the study conduct. Decisions remain with the study director, in accordance with GLP.