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QA-Clinical ☆ 2008-10-04 10:44 (6065 d 23:49 ago) Posting: # 2479 Views: 3,515 |
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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 |
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H_Rotter ★ Germany, 2008-10-04 14:30 (6065 d 20:02 ago) @ QA-Clinical Posting: # 2483 Views: 2,774 |
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Dear QA-Clinical (what a name - maybe you should consider adding a signature to your profile)! ❝ Does this mean that the Impartial witness CANNOT be another volunteer in the study? IMHO short answer: see above. Regards, Hermann |
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QA-Clinical ☆ 2008-10-08 10:26 (6062 d 00:07 ago) @ H_Rotter Posting: # 2492 Views: 2,780 |
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Hi Hermann, Can you provide any guideline / regulatory / FDA Warning letter, some basis with which your answer can be defended? Thanks and Regards, — Diggavi |
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Ohlbe ★★★ France, 2008-10-09 01:57 (6061 d 08:36 ago) @ QA-Clinical Posting: # 2496 Views: 2,783 |
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Dear Diggavi, The answer is in the definition you gave: "who is independent from the trial". Another subject is not really "independent", and some people could say that the witness was influenced into signing, being afraid of not getting enrolled into the trial himself if he refused to sign. Why do you want to enroll illiterate subjects for ??? Don't you have enough subjects who can read and understant what they are signing for themselves ? If for any reason you really want to have illiterate subjects in your trial, pay even more attention than usual to the wording of the informed consent form. Regards Ohlbe |
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QA-Clinical ☆ 2008-10-11 10:06 (6059 d 00:27 ago) @ Ohlbe Posting: # 2510 Views: 2,782 |
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Dear Ohlbe, Thanks for the information. It was enlightening. However, I would like to add that recruiting subjects would have lots of practical problems and that's one of the reasons why such situations arise. An ideal situation would be where there are minimal or no illiterate volunteers registered in the databank to ensure maximum compliance towards ethics and GCP. Thanks and Regards, QA-Clinical — Diggavi |
Ing. Helmut Schütz