Elements of Informed Consent [Regulatives / Guidelines]

posted by amatewadi  – Pune, 2012-02-24 08:53 (5239 d 00:17 ago) – Posting: # 8168
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(edited on 2012-02-24 10:00)

It is important to give straightforward facts. It is very doubtful that many volunteers could begin to understand this section. as What is being listed is the SmPC/ protocol/ IB/ PIL information for physicians, not an appraisal of what a volunteer should know about the side effects of a single dose. as long-term AEs will NOT be seen. So, the ICF needs to inform volunteers about what could happen (simply) in single dose given to them.

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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