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RegisterDeviation in Dosing as per Randomisation schedule [GxP / QC / QA]
Dear All,
In double blind, three treatment study design - what are the resolution steps if Dosing treatment of two subjects have been interchange during Period - 1 ? Should we consider those two subjects continue for remaining study - if still Period 2 and Period 3 are remain ?
Is there any effect of it on result of study data?
Regards,
Mrugank
Edit: Category changed. [Helmut]
In double blind, three treatment study design - what are the resolution steps if Dosing treatment of two subjects have been interchange during Period - 1 ? Should we consider those two subjects continue for remaining study - if still Period 2 and Period 3 are remain ?
Is there any effect of it on result of study data?
Regards,
Mrugank
Edit: Category changed. [Helmut]
Complete thread:
- Deviation in Dosing as per Randomisation scheduleMrugank 2012-08-18 18:22
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Double blind – or not? Helmut 2012-08-19 23:47
- Double blind – or not? Mrugank 2012-08-20 16:37
- Major protocol deviation Helmut 2012-08-20 16:52
- Double blind – or not? Mrugank 2012-08-20 16:37
- Double blind – or not? Helmut 2012-08-19 23:47
Ing. Helmut Schütz