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RegisterDouble blind – or not? [GxP / QC / QA]
Dear Helmut,
Randomization schedule has not been opened by PI till yet. Matter is we have dosed to two subjects interchangeably.
e.g. Subject Number 02 has been administered a treatment of subject Number 03 and vice versa.
Weather is it acceptable in any way ? Should we consider this two subjects continue for remaining study by shifting of treatment of both subjects in all 3 period?
Regards,
Mrugank
Randomization schedule has not been opened by PI till yet. Matter is we have dosed to two subjects interchangeably.
e.g. Subject Number 02 has been administered a treatment of subject Number 03 and vice versa.
Weather is it acceptable in any way ? Should we consider this two subjects continue for remaining study by shifting of treatment of both subjects in all 3 period?
Regards,
Mrugank
Complete thread:
- Deviation in Dosing as per Randomisation schedule Mrugank 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