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RegisterSuggestions needed [Regulatives / Guidelines]
Dear raghavendra
Note for Guidance on Good Clinical Practice, CPMP/ICH/95, ICH Topic E6
I would categorize the deviations you mentioned according to EMEA as critical: Conditions, practices or processes that adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data.
A major deviation would be: Conditions, practices or processes that might adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data. Major observations are serious deficiencies and are direct violations of GCP principles
The sponsor will be obliged to repeat the study on cost of the CRO.
Kind regards
Dan
Note for Guidance on Good Clinical Practice, CPMP/ICH/95, ICH Topic E6
I would categorize the deviations you mentioned according to EMEA as critical: Conditions, practices or processes that adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data.
A major deviation would be: Conditions, practices or processes that might adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data. Major observations are serious deficiencies and are direct violations of GCP principles
The sponsor will be obliged to repeat the study on cost of the CRO.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Errors in sample collection tube labels raghavendra_s 2010-01-27 10:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Suggestions needed raghavendra_s 2010-02-18 06:22
- Suggestions neededDr_Dan 2010-03-12 11:47
- Suggestions needed raghavendra_s 2010-02-18 06:22
Ing. Helmut Schütz