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RegisterCriteria check assessment of subjects [GxP / QC / QA]
Dear Kapil!
Ok, now I got it. In CROs I know, the MSR after release by the physician (a qualified subinvestigator who has to to be named in the study report) is not signed by the PI.
But: the PI confirms suitability of subjects directly in the CRFs, not in a separate document. You can have a separated document additionally, if you want.
Hope that helps.
❝ To summarise, whether the PI should sign in the Medicals Screening Records as an evidence that the subect suitability was systematically given after proper review of screenign status or a mere statement by the PI suffice this purpose.
Ok, now I got it. In CROs I know, the MSR after release by the physician (a qualified subinvestigator who has to to be named in the study report) is not signed by the PI.
But: the PI confirms suitability of subjects directly in the CRFs, not in a separate document. You can have a separated document additionally, if you want.
Hope that helps.
—
Regards, Jaime
Regards, Jaime
Complete thread:
- Criteria check assessment of subjects kapil pandya 2010-11-12 12:43 [GxP / QC / QA]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 subjectsJaime_R 2010-11-15 14:48
- Criteria check assessment of subjects Dr_Dan 2010-11-16 11:19
- Criteria check assessment of subjects maulik963 2012-05-12 18:11
- Criteria check assessment of subjects Dr_Dan 2012-05-14 15:35
- Criteria check assessment of subjects maulik963 2012-05-12 18:11
- Criteria check assessment of subjects Dr_Dan 2010-11-16 11:19
- Criteria check assessment of subjectsJaime_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
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