Multiple Enrollments and Multiple Screenings

Pinnacle 21 Support SDTM
1

Hi Marnie,

Per my understanding, it’s due to a fact that all analysis and reviews are performed by a complete subject experience (USUBJID), not by subject enrolment in the study(ies) (SUBJID).

Kind Regards,
Sergiy

2

Hi,

I have some question about multiple enrollments and multiple screenings.

In 2014, PhUSE WG suggested to update the structure of DM to “One records per SUBJID”. However, the FDA and CDISC did not adopt this recommendation and insist that the structure of DM should be maintained as “One records per USUBJID”.
So, I want to know the reason why the DM data set must satisfy “One records per USUBJID”. How will this help the review process?

Kind Regards,

Marnie