Bioequivalence and Bioavailability Forum • Role of Monitor

Ken Peh
★

Malaysia,
2014-04-02 11:34
(3666 d 21:12 ago)

Posting: # 12755
Views: 3,585

Role of Monitor [GxP / QC / QA]

Dear All,

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

Your comment is highly appreciated.

Thank you.

Regards,
Ken

Edit: Category changed; removed “Re: ” from the subject line. [Helmut]

Irukulla Shravan Kumar
★

India,
2014-04-03 10:53
(3665 d 21:53 ago)

@ Ken Peh
Posting: # 12762
Views: 2,874

Role of Monitor

Post reply

❝ 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.

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]