Deviation in maintaining Fed breakfast [Study Per­for­mance]

posted by Pankaj – India, 2010-08-16 08:45 (5785 d 02:19 ago) – Posting: # 5791
Views: 3,707
(edited on 2010-08-16 12:23)

Dear Members,
Please give your valuable inputs for the following queries:
  1. Recently carried out one fed study (Europe Submission) where the restriction of 30 minutes from start of breakfast to dosing wasn't maintained (Deviation ranging from 02 to 07 minutes) for more than 50% of the sample size. Now since the clinical part is over, should we go for analysis or to withdraw the subjects samples before start of analysis.
  2. Should a protocol deviation be enough to suffix the problem?
Anticipating your valuable suggestions at the earliest.

Pankaj

Edit: Category changed. [Jaime]

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