Subjects rights [Regulatives / Guidelines]

posted by Ohlbe – France, 2016-05-09 13:03 (3199 d 11:57 ago) – Posting: # 16283
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Dear Krish,

❝ Can any one let me know what are the rights of subjects participating in clinical trials.


There is no list of subjects rights in ICH GCP, at least nothing worded as such. But you can derive them from the obligations of other parties. For instance:

If you really want to build a list, make sure to also take into consideration the Declaration of Helsinki and your national laws, regulations and recommendations. And don't forget to specify that the subjects rights "include, but are not limited to" items on your list.

Regards
Ohlbe

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