jag009
★★★

NJ,
2018-07-11 21:27

Posting: # 19034
Views: 1,220
 

 Definition of Enrolled subject [Study As­sess­ment]

Hi all,

Sort of a strange question but what are considered as enrolled subjects? Should standby subjects, the ones who are present at dosing to replace the original "panel" subjects in case they are dropped/withdrew prior to dosing in period 1, be included in the enrolled subject demographic table? Note that these standby subjects will not be dosed (and leave the clinic) if all original subjects get dosed in period 1.

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

Thanks
John
Ohlbe
★★★

France,
2018-07-12 00:07

@ jag009
Posting: # 19035
Views: 1,057
 

 Definition of Enrolled subject

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
jag009
★★★

NJ,
2018-07-17 06:36

@ Ohlbe
Posting: # 19075
Views: 936
 

 Definition of Enrolled subject

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" :no:

John
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