Post by Alira Health

We’re excited to share a new paper co-authored by Laura Datko Williams and Andrea Gardani and presented by Laura at PharmaSUG 2026.    As clinical studies increasingly allow rescreening and multiple enrollments, sponsors face a challenging question: how should these subjects be represented in SDTM for regulatory submissions? This paper explores the current guidance from CDISC and FDA, proposed future approaches, and practical SDTM examples, including handling USUBJID assignment and common Pinnacle21 findings. If you work with clinical data standards, regulatory submissions, or SDTM implementation, this is a timely read.