Bioequivalence and Bioavailability Forum

Dear Konkous

❝ During the conduct of a BE study is it allowed for the Study Monitor to be present

Yes. But there are some activities which he should not be allowed to witness, such as the medical examination of a subject, or a medical discussion between a subject and the investigator, sub-investigator or medical person.

❝ and participate in any activity or not ?

Well... What do you exactly mean with "participate in any activity" ? He can do any monitoring activity described in GCP. But he should not be involved in the performance of the trial itself. You should maintain a clear separation between investigator responsibilities and activities (see Chapter 4 of ICH GCP) and sponsor responsibilities and activities, which include monitoring (see Chapter 5 of ICH GCP).

Regards
Ohlbe