Protocol Compliance [GxP / QC / QA]
Dear Mr.Raghavendra,
It is advisable to do the safety laboratory evaluation on the day of arrival of subject even it deviates from the protocol and the same should be addressed as protocol deviation.
Regards,
Dr.S.Gunasakaran,MBBS,MD
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 is advisable to do the safety laboratory evaluation on the day of arrival of subject even it deviates from the protocol and the same should be addressed as protocol deviation.
Regards,
Dr.S.Gunasakaran,MBBS,MD
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]
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- Protocol Compliance raghavendra_s 2010-04-03 09:53
- Protocol Compliance Dr.Sridhar 2010-04-03 11:04
- Protocol Compliancedrgunasakaran1 2010-04-03 13:20
- Post treatment safety after 30+ days? Helmut 2010-04-03 14:38
