Bioequivalence and Bioavailability Forum • Criteria check assessment of subjects

Criteria check assessment of subjects [GxP / QC / QA]

posted by Dr_Dan – Germany, 2012-05-14 17:35 (5141 d 14:27 ago) – Posting: # 8567
Views: 7,634

Dear Maulik963
If a subject passes (generalized) screening this does not automatically mean that this subject is enrolled into the study. If you know that the inclusion criteria for your specific study are different to the ones of the generalized screening then you have to re-asses your screening in order to verify the in-/exclusion criteria. This has to be documented. Enrolment has to be done by the PI or his/her delegate on basis of the re-assed data.
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Criteria check assessment of subjects kapil pandya 2010-11-12 12:43 [GxP / QC / QA]
- 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 subjects maulik963 2012-05-12 18:11
        
        Criteria check assessment of subjectsDr_Dan 2012-05-14 15:35