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RegisterDefinition of Enrolled subject [Study Assessment]
Hi John,
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.
❝ 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.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Definition of Enrolled subject jag009 2018-07-11 21:27 [Study Assessment]
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- Definition of Enrolled subjectOhlbe 2018-07-12 00:07
- Definition of Enrolled subject jag009 2018-07-17 06:36
- Definition of Enrolled subjectOhlbe 2018-07-12 00:07
Ing. Helmut Schütz