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RegisterCriteria check assessment of subjects [GxP / QC / QA]
Dear Sir,
I am little fresher to this field hence it is possible that my views may not be clear but still i have some comments to mention.
What if in the case where CRO does the Generalized screening (means not study specific) then the evaluated Screening results will includes the generalized criteria which are being followed by all the regulatories.
Not if we are doing study for Canada submission, then BMI range will be stringent than other regulatory or if we are conducting study for Brazil where we can not include Volunteer? should PI review MSR before consider volunteer eligible for the study?
I Hope you have got my point.
With Regards
I am little fresher to this field hence it is possible that my views may not be clear but still i have some comments to mention.
What if in the case where CRO does the Generalized screening (means not study specific) then the evaluated Screening results will includes the generalized criteria which are being followed by all the regulatories.
Not if we are doing study for Canada submission, then BMI range will be stringent than other regulatory or if we are conducting study for Brazil where we can not include Volunteer? should PI review MSR before consider volunteer eligible for the study?
I Hope you have got my point.
With Regards
Complete thread:
- Criteria check assessment of subjects kapil pandya 2010-11-12 12:43
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- Criteria check assessment of subjects Jaime_R 2010-11-12 13:45
- Criteria check assessment of subjects kapil pandya 2010-11-15 04:49
- Criteria check assessment of subjects Jaime_R 2010-11-15 14:48
- Criteria check assessment of subjects Dr_Dan 2010-11-16 11:19
- Criteria check assessment of subjectsmaulik963 2012-05-12 18:11
- Criteria check assessment of subjects Dr_Dan 2012-05-14 15:35
- Criteria check assessment of subjectsmaulik963 2012-05-12 18:11
- Criteria check assessment of subjects Dr_Dan 2010-11-16 11:19
- Criteria check assessment of subjects Jaime_R 2010-11-15 14:48
- Criteria check assessment of subjects kapil pandya 2010-11-15 04:49
- Criteria check assessment of subjects Jaime_R 2010-11-12 13:45
Ing. Helmut Schütz