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RegisterProtocol deviation [Study Assessment]
Dear All
If we conduct the bioequivalence with clinical end points and there are deviations in the conduct of the study e.g. included patients do not meet the entry criteria or change in dose timing. however, the results show that these deviations have not effected the outcomes and there is treatment success. however, these may result in AE.
Should we include such subjects in final data analysis for BE or these should be excluded?
Regards
Ghousia
Edit: Category and subject line modified. [Helmut]
If we conduct the bioequivalence with clinical end points and there are deviations in the conduct of the study e.g. included patients do not meet the entry criteria or change in dose timing. however, the results show that these deviations have not effected the outcomes and there is treatment success. however, these may result in AE.
Should we include such subjects in final data analysis for BE or these should be excluded?
Regards
Ghousia
Edit: Category and subject line modified. [Helmut]
Complete thread:
- Protocol deviationGhousia Saba 2014-10-17 12:37
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Protocol deviation priya 2014-10-17 15:48
Ing. Helmut Schütz