Regarding Protocol Deviation [GxP / QC / QA]

posted by Dr.Pravin – Ahmedabad, 2009-02-12 11:25 (6342 d 22:12 ago) – Posting: # 3227
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Dear HS,

I just want to know that From which point of time we can consider protocol deviation.

Case: One subject was enrolled in study, he was checked in and on the dosing he was consume water within pre dose water restriction time, he was discontinue from the trial based on protocol non complience,

whether it should be consider as Protocol Deviation or not.

Dr.Pravin Ahir
Co-Investigator,
Accutest Research Pvt.Lab.(I), Ltd.
Ahmedabad

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