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RegisterChange in study design and required approval [Regulatives / Guidelines]
Dear Docksr;
Amendment in the basic study design should be notified to DCGI and approval is required before teh study initiation.
And there is another clause;
if you have three way with two sequence (T1RT2 & RT1T2); you can initiate the study and terminate the last period (T2). reason for terminating the last period should be stated in report, and the section change in conduct of the study to be updated with a deviation filled.
Regards
K@K
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Amendment in the basic study design should be notified to DCGI and approval is required before teh study initiation.
And there is another clause;
if you have three way with two sequence (T1RT2 & RT1T2); you can initiate the study and terminate the last period (T2). reason for terminating the last period should be stated in report, and the section change in conduct of the study to be updated with a deviation filled.
Regards
K@K
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
- Change in study design and required approval docksr 2013-07-10 11:13
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Change in study design and required approval Dr sridevi 2013-07-10 12:28
- Change in study design and required approval Naveen Kumar 2013-07-11 09:50
- Change in study design and required approvalKarthikeyan 2013-07-15 13:31
- Three-way with two sequences? Helmut 2013-07-15 13:43
- Three-way with two sequences? Karthikeyan 2013-07-16 06:10
- Period effects! Helmut 2013-07-16 13:53
- Three-way with two sequences? Karthikeyan 2013-07-16 06:10
- Three-way with two sequences? Helmut 2013-07-15 13:43
Ing. Helmut Schütz