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RegisterReplicate study / two groups [Design Issues]
Dear Mr Santosh,
You cannot change the Study design (from single group to multiple groups) during the study execution for the reason of shortage of volunteers. It is a major protocol violation. If you have captured the execution of studies in groups in the EC approved protocol itself, then you can execute the study. In that case, it is preferable to dose in two groups for the remaining periods also.
❝ But in First period due to short of Volunteers we planned to do study in two groups with 20 subject in each group.
You cannot change the Study design (from single group to multiple groups) during the study execution for the reason of shortage of volunteers. It is a major protocol violation. If you have captured the execution of studies in groups in the EC approved protocol itself, then you can execute the study. In that case, it is preferable to dose in two groups for the remaining periods also.
—
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:
- Replicate study / two groups santosh 2012-12-21 13:37
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Replicate study / two groupsdrgunasakaran1 2012-12-22 12:20
- Replicate study / two groups santosh 2012-12-24 08:09
- Replicate study / two groups Dr_Dan 2012-12-27 12:17
- Replicate study / two groups santosh 2012-12-27 12:34
- TOFU Helmut 2012-12-27 14:50
- Replicate study / two groups santosh 2012-12-27 12:34
- Replicate study / two groups Dr_Dan 2012-12-27 12:17
- Replicate study / two groups santosh 2012-12-24 08:09
- Replicate study / two groupsdrgunasakaran1 2012-12-22 12:20
Ing. Helmut Schütz