Frequent Queries from FDA: Gender Imbalance [Regulatives / Guidelines]

posted by jag009  – NJ, 2022-11-22 08:02 (510 d 05:23 ago) – Posting: # 23373
Views: 1,969

Hi,

❝ Please feel free to share your experience if anyone has recieved similary queries and what justification was provided.


I am sorry but whenever I run a BE study I always ask for 60/40 split. I might allow 70/30 split depending on the sample size. If the site cannot accommodate my request then I will go somewhere else. So far I haven't received any queries from FDA.

J

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