Ken Peh
★    

Malaysia,
2014-04-02 11:34
(3648 d 09:11 ago)

Posting: # 12755
Views: 3,498
 

 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
(3647 d 09:52 ago)

@ Ken Peh
Posting: # 12762
Views: 2,806
 

 Role of Monitor

❝ 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]
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