Obtaining Informed Consent [GxP / QC / QA]

posted by Dr_Dan  – Germany, 2013-08-13 16:34 (4692 d 19:48 ago) – Posting: # 11269
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Dear Irukulla Shravan Kumar
Please apologize but I do not understand your question.
  1. informed consent must be signed before enrolment of the subject into the study
  2. mental disorders must be excluded except that the study is in patients with mental disorders. Then losing consciousness or competence during the research period is an expected AE. Nevertheless, the subject did know that when giving his consent. A subjectś legally acceptable representative can give consent in other cases. However, I suggest to study the guideline for good clinical practice CPMP/ICH/135/95
I hope this helps.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan

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