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RegisterMajor protocol deviation [GxP / QC / QA]
posted by Helmut 
– Vienna, Austria, 2012-08-20 18:52 (5047 d 23:10 ago) – Posting: # 9085
Views: 5,260
Dear Mrugank!
Sorry, I misinterpreted your first post.
It should be possible, but:
❝ 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.
Sorry, I misinterpreted your first post.
❝ 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?
It should be possible, but:
- I would say that’s a major protocol deviation.
- It casts a damning light on your procedures. How did you detect the error? Can you confirm that the other subjects were dosed correctly?
- Be prepared for an inspection.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 deviationHelmut 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