Bioequivalence and Bioavailability Forum

❝ How extensive should a monitor be involved in monitoring the clinical part of BE study ?

Dear, There is no limit for monitoring of study activities. This depends on how you describe with your internal procedures like coverage of audits under inprocess or retrospective scope.

❝ Should a monitor do the first line checking of all the data entries ? My understanding of guideline of role of monitor is to check and verify the documents. The monitor is not expected to work as a team member of a study team.

The monitor should always act independently from the study execution team members.

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Edit: Full quote removed, standard quotes restored. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]