Role of Monitor [GxP / QC / QA]

posted by Ken Peh – Malaysia, 2014-04-02 11:34 (4455 d 05:56 ago) – Posting: # 12755
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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]

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