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RegisterImpartial Witness [Regulatives / Guidelines]
Hi everybody,
ICH E6 says "Impartial Witness: A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject."
Does this mean that the Impartial witness CANNOT be another volunteer in the study?
Regards,
QA-Clinical
ICH E6 says "Impartial Witness: A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject."
Does this mean that the Impartial witness CANNOT be another volunteer in the study?
Regards,
QA-Clinical
Complete thread:
- Impartial WitnessQA-Clinical 2008-10-04 08:44 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Impartial Witness H_Rotter 2008-10-04 12:30
- Impartial Witness QA-Clinical 2008-10-08 08:26
- Impartial Witness Ohlbe 2008-10-08 23:57
- Impartial Witness QA-Clinical 2008-10-11 08:06
- Impartial Witness Ohlbe 2008-10-08 23:57
- Impartial Witness QA-Clinical 2008-10-08 08:26
- Impartial Witness H_Rotter 2008-10-04 12:30
Ing. Helmut Schütz