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Post: coding adverse events

Jelf
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Posts: 1

Registered on 01-15-07

01-15-07 05:04 AM - Post#3785

Our study is not using a standard medical dictionary (ie MedDRA), instead the team created a short list of expected adverse events. As we analyze our data we're now faced with a gigantic number of "Other" AEs and the possibility of expanding our code list (dictionary). If we change our AE dictionary mid-study are there any pot holes to watch out for?

Thank you for offering your perspective.

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