Bioequivalence and Bioavailability Forum

Definition of Enrolled subject [Study As­sess­ment]

posted by jag009  – NJ, 2018-07-17 08:36 (2108 d 13:09 ago) – Posting: # 19075
Views: 2,998

Thanks Ohlbe

❝ 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.

That's my thinking as well. I asked the CRO and their reply was "That's how our clinic has been doing it"

John

Complete thread:

• Definition of Enrolled subject jag009 2018-07-11 21:27 [Study As­sess­ment] 
  • Definition of Enrolled subject Ohlbe 2018-07-12 00:07
    • Definition of Enrolled subjectjag009 2018-07-17 06:36