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yogesh1004 ☆ India, 2012-10-09 08:36 (4595 d 11:39 ago) Posting: # 9345 Views: 5,458 |
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Dear All, When a Informed consent is designed for single dose two way crossover BABE study, is it necessary to document all the adverse events described in the label? As the label will have the adverse events observed in the clinical studies (in patients, adverse events observed in combination studies and also the adverse events observed in multiple dose studies. Is it is also necessary to document the adverse events reported for that molecule as mentioned in the label in Protocol and Informed consent form? Or is it is sufficient to write the adverse events observed with out the study details and percentages. recently FDA issued an 483 in this aspect to one of the CRO. Please guide me in this regard. Regards, S.Yogesh Edit: Category changed. [Helmut] |
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cakhatri ★ India, 2012-10-09 09:38 (4595 d 10:37 ago) (edited on 2012-10-09 10:08) @ yogesh1004 Posting: # 9349 Views: 4,611 |
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Dear Yogesh, If I were to decide, I would list all possible AEs with their percentage in the Protocol and ICF, because on ehtical grounds a company conducting trials on healthy human subjects is supposed to provide every minute details that is available for the product, and if not described in ICF and with even minor chances of occurrence during the study may lead to gross ethical negligence. Opinion from other members welcome Regards Chirag Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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yogesh1004 ☆ India, 2012-10-10 08:29 (4594 d 11:46 ago) (edited on 2012-10-10 10:11) @ cakhatri Posting: # 9367 Views: 4,563 |
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drgunasakaran1 ★★  2012-10-09 22:24 (4594 d 21:51 ago) @ yogesh1004 Posting: # 9366 Views: 4,614 |
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Dear Mr Yogesh, ❝ Is it is also necessary to document the adverse events reported for that molecule as mentioned in the label in Protocol and Informed consent form? Yes. It is mandatory to document all the adverse events reported in the SmPC/Prescribing Information in the Informed Consent Document. ❝ Or is it is sufficient to write the adverse events observed with out the study details and percentages. No. Will not be accepted by the Regulatory Authorities. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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yogesh1004 ☆ India, 2012-10-10 08:30 (4594 d 11:45 ago) (edited on 2012-10-10 10:11) @ drgunasakaran1 Posting: # 9368 Views: 4,532 |
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Ing. Helmut Schütz