Bioequivalence and Bioavailability Forum

Dear Mr Constantinos,

❝ During the conduct of a BE study is it allowed for the Study Monitor to be present and participate in any activity or not?

Yes. The Study monitor can be present and monitor the study activities during BE study execution phase.

❝ Is there a specific guideline addressing this issue?

See here, 5.18 Monitoring section, ICH E6 (R1), Guideline for Good Clinical Practice

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