isra_amm
●    

2007-08-21 16:33
(6874 d 05:27 ago)

Posting: # 996
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 protocol review [GxP / QC / QA]

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Our QA personnel refuse to review the protocol as one of the reviewers and insist on reviewing it as an audit after being reviewed from the different departments.
Do the QA participate in the review of the BE protocol before submission to the IRB?
Who are the reviewers of the protocol before submission to the IRB? is there a guideline regarding this or it is a general GCP ??
 
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