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Definition of Enrolled subject [Study As­sess­ment]

posted by Ohlbe - France, 2018-07-12 00:07  - Posting: # 19035
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Hi John,

» A few CROs said the standbys should be included in the "enrolled subject demographic table"

IMHO they should be listed on the inclusion log in the TMF, but I don't see the point in adding their data to the demographics table. They were not dosed and their data are not used in any way to assess BE.

Regards
Ohlbe

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