Bioequivalence and Bioavailability Forum • Criteria check assessment of subjects

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

posted by Dr_Dan – Germany, 2010-11-16 12:19 (5686 d 07:30 ago) – Posting: # 6149
Views: 8,481

Dear Kapil, dear Jaime and all others
To my understanding the PI does not to have to sign the screening results regardless if they are recorded on source documents or transcribed to the CRF. By declaring that the particular subject is suitable for the study he/she declares automatically that he/she reviewed all available information. The PI is personally responsible for the safety of the subjects and therefore has to inform him/herself, so the screening results could be signed by different (sub-) investigators trained by the PI.
Hope this helps.
Kind regards
Dan

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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 subjectsDr_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