Adverse Event [Study Per­for­mance]

posted by Neeraj – 2009-02-06 12:07 (6340 d 20:47 ago) – Posting: # 3188
Views: 6,475

Dear all,

In a two-way cross over study, during pre study dinner (after check-in) a subject got an adverse event in Period II. The subject was given Test drug in Period I and necessary wash out period was maintained. How to report the event in final study report? As a predose adverse event or due to test drug?

Regards,
Neeraj

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