Inclusion and Exclusion criteria [GxP / QC / QA]

posted by kaushik089 – India, 2012-06-15 15:31 (5114 d 14:20 ago) – Posting: # 8743
Views: 4,898

hello dear varsha

❝ My question is whether exclusion criteria shall be maintained only during period 01 Check-in or for all the periods check-in.


NO, we have to follow for both the periods.

and also if suppose we have not comply to the exclusion criterias for period 02 what should be our stand?

should withdraw the subject immediately followed by raising an adverse event will appropriate.


kaushik panigrahi

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