Inclusion criteria (ANVISA) [Regulatives / Guidelines]

posted by BRB  – Canada, 2018-04-05 00:18 (1595 d 17:50 ago) – Posting: # 18642
Views: 3,927

(edited by Ohlbe on 2018-04-05 09:12)

Hello all,

» It should be minimum 6 months as per new guideline.

Is the 6 month time frame only between studies for ANVISA submission? I would think that's the case.

Hypothetically, could a subject participate in another study for another agency (e.g. the FDA) 30 days after doing a study for ANVISA taking into account their 6 month lock out requirement?

Thanks!
BRB


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! [Ohlbe]

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