Neeraj
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2009-02-06 12:07
(5998 d 04:28 ago)

Posting: # 3188
Views: 5,383
 

 Adverse Event [Study Per­for­mance]

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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
 
Helmut
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Vienna, Austria,
2009-02-06 13:35
(5998 d 03:00 ago)

@ Neeraj
Posting: # 3190
Views: 4,006
 

 Adverse Event

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Dear Neeraj,

there's no category like 'predose adverse event'. It's an AE, full stop (in one of our studies a volunteer was bitten by a dog in the washout - still that's an AE). The investigator should rate the relationship of the AE to the study medication. The rating scale hopefully is given in both the protocol and the CRF. IMHO most investigators would rate such an AE as 'unlikely'.
For examples of rating scales see this post.
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