Check in delay [GxP / QC / QA]

posted by raghavendra_s – 2010-02-18 07:18 (5962 d 10:45 ago) – Posting: # 4782
Views: 6,186

Dear Sir,

In a BA/BE study, on the day of check-in due to unavoidable reasons if the check-in happens late night say about 12midnight, is it ok with the restrictions and prohibitions mentioned in the protocol as they are going to file protocol deviation for the same. (eg: fasting restrictions of at least 10 hours before receiving the study drug?).

Kindly suggest.

Thanks and regards,

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