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RegisterProtocol deviation [Study Performance]
Hi Helmut
You are thinking of a cross over design (within subject comparison), but what would you do in case of a parallel design study? Then it could make sense to perform the BE assessment excluding these subjects....
However, I agree that these deviations increase doubts on the CRO's procedures not complying with the protocol. They should be prepared for an inspection if this is a pivotal study to be submitted to regulatory authorities.
Kind regards
Dan
You are thinking of a cross over design (within subject comparison), but what would you do in case of a parallel design study? Then it could make sense to perform the BE assessment excluding these subjects....
However, I agree that these deviations increase doubts on the CRO's procedures not complying with the protocol. They should be prepared for an inspection if this is a pivotal study to be submitted to regulatory authorities.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Subject selected into study with BMI not as per protocol vivekanand 2013-04-29 14:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Subject selected into study with BMI not as per protocol jag009 2013-04-29 15:17
- Subject selected into study with BMI not as per protocol Ohlbe 2013-04-29 16:45
- Protocol deviation Helmut 2013-04-29 15:20
- Protocol deviationDr_Dan 2013-04-29 16:54
- Protocol deviation Helmut 2013-04-29 17:26
- Protocol deviationDr_Dan 2013-04-29 16:54
- Subject selected into study with BMI not as per protocol sarada06884 2013-04-30 12:34
- Subject selected into study with BMI not as per protocol jag009 2013-04-29 15:17
Ing. Helmut Schütz