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RegisterBMI limits [Design Issues]
Dear Amira,
» if principal investigator approved this deviation (31.5), recorded in protocol deviation log and submitted to IRB/IEC, what do you think?
That it is still a protocol deviation, and non-compliance with ICH GCP sections 4.5.1 and 4.5.2. Unlikely to cause the rejection of the trial, but if there are too many of these, it may trigger questions and possibly an inspection.
» if principal investigator approved this deviation (31.5), recorded in protocol deviation log and submitted to IRB/IEC, what do you think?
That it is still a protocol deviation, and non-compliance with ICH GCP sections 4.5.1 and 4.5.2. Unlikely to cause the rejection of the trial, but if there are too many of these, it may trigger questions and possibly an inspection.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- BMI Amira Gouda 2018-10-30 10:48 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BMI limits Ohlbe 2018-10-30 11:42
- BMI limits Amira Gouda 2018-10-30 23:06
- BMI limitsOhlbe 2018-10-30 23:48
- BMI limits ElMaestro 2018-10-31 09:19
- BMI limits Amira Gouda 2018-10-31 13:59
- BMI limits Amira Gouda 2018-10-30 23:06
- BMI limits Ohlbe 2018-10-30 11:42
Ing. Helmut Schütz