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RegisterProtocol Compliance [GxP / QC / QA]
Dear Raghavendra,
It will be better to safety analysis to be on safer side because this will prove that subject lost to follow up was due to his personal problems or not due to any Adverse event with your drug.
And you can also file an protocol deviation for same with proper explanation.
Regards,
Dr.Sridhar
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
It will be better to safety analysis to be on safer side because this will prove that subject lost to follow up was due to his personal problems or not due to any Adverse event with your drug.
And you can also file an protocol deviation for same with proper explanation.
Regards,
Dr.Sridhar
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
- Protocol Compliance raghavendra_s 2010-04-03 09:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Protocol ComplianceDr.Sridhar 2010-04-03 11:04
- Protocol Compliance drgunasakaran1 2010-04-03 13:20
- Post treatment safety after 30+ days? Helmut 2010-04-03 14:38
Ing. Helmut Schütz