yatish gosai ☆ India, 2019-05-22 09:49 (2001 d 11:24 ago) Posting: # 20289 Views: 8,125 |
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Can Husband act as an Impartial witness for Screening and Enrollment of his wife in BABE study? Yatish Gosai QA Professional Edit: Category changed; see also this post #1. [Helmut] |
Ohlbe ★★★ France, 2019-05-22 12:48 (2001 d 08:25 ago) @ yatish gosai Posting: # 20290 Views: 7,182 |
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Dear Yatish Gosai, ❝ Can Husband act as an Impartial witness for Screening and Enrolment of his wife in BABE study? I could not find a definition of an "impartial witness" in the New Drugs and Clinical Trials Rules, 2019. ICH GCP § 1.26 defines the impartial witness as 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. In a Phase 3 trial I would say yes as there is no financial benefit. In a BA/BE trial, one may object that the husband has a direct interest in having his wife participate (he will benefit from the money). The husband is not impartial as he may be influenced by the financial incentive... The wife's consent may not be freely given (particularly in the case of illiterate subjects, which is the situation where you would need an impartial witness, where wifes are used to obeying their husband). — Regards Ohlbe |
yatish gosai ☆ India, 2019-05-22 13:04 (2001 d 08:09 ago) @ Ohlbe Posting: # 20292 Views: 7,215 |
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Thanks for valuable opinion Yatish Gosai Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
Helmut ★★★ Vienna, Austria, 2019-05-24 14:20 (1999 d 06:53 ago) @ Ohlbe Posting: # 20300 Views: 7,220 |
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Dear Ohlbe and all, ❝ I could not find a definition of an "impartial witness" in the New Drugs and Clinical Trials Rules, 2019. Thank you for pointing me to this reference! Unfortunately BE is wrongly defined (Chapter I, 2. Definitions (f), page 148): “bioequivalence study” means a study to establish the absence of a statistically significant difference in the rate and extent of absorption of an active ingredient from a pharmaceutical formulation in comparison to the reference formulation having the same active ingredient when administered in the same molar dose under similar conditions; (my emphases)One error and a doubtful term:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Helmut ★★★ Vienna, Austria, 2019-05-22 12:52 (2001 d 08:21 ago) @ yatish gosai Posting: # 20291 Views: 7,271 |
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Hi Yatish, ❝ Can Husband act as an Impartial witness for Screening and Enrollment of his wife in BABE study? Look up impartial in a dictionary. A married couple is a paradigm of not being impartial. See the definition of impartial witness in the ‘Ethical Guidelines for Biomedical Research on Human Subjects’ of the Indian Council of Medical Research: A literate person, who is independent of the research and would not be unfairly influenced by people involved with the study, who attends the informed consent process if the participant […] cannot read, and understand the informed consent form and any other written information supplied to the participant. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
yatish gosai ☆ India, 2019-05-22 13:04 (2001 d 08:08 ago) @ Helmut Posting: # 20293 Views: 7,212 |
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Thanks for valuable opinion Yatish Gosai Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
nobody nothing 2019-05-22 17:56 (2001 d 03:16 ago) @ yatish gosai Posting: # 20294 Views: 7,146 |
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These are no "opinions" (i.e. subjected to matters of taste or which can be discussed), these are facts. And it's amazing (to say the least) that such a question arises in the first place in a forum for BA/BE experts... — Kindest regards, nobody |
ElMaestro ★★★ Denmark, 2019-05-22 18:11 (2001 d 03:02 ago) @ yatish gosai Posting: # 20295 Views: 7,181 |
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Hi yatish gosai and all posters on this thread, to be honest I think this is a great, great question and it is one that made me think very hard for a prolonged moment. The mere fact that such a question is asked should give rise to a lot of reflection on the part of regulators. What is obvious to a regulator or someone from one geographical region is obviously not obvious to others. At the end of the day guidelines are not intended solely for regulators but for all involved parties. So here's something to work with. — Pass or fail! ElMaestro |