Date and Time:
TUE 10 NOV 2020, 11:00 AM - 12:30 PM Eastern US Standard Time
Description:
Join us as we discuss Public Review for CDASH SAE v2.0 Supplement.
CDISC, with support from our partner TransCelerate Biopharma, is developing version 2.0 of the CDASH SAE Supplement, which will capture how to structure serious adverse events (SAE) concepts for regulated clinical trials. It will also align with E2B (R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide – Data Elements and Message Specification and bring the standard up to date with current CDISC standards.
Public Review is a key quality step in the development of this supplement for the research community. We invite you to contribute your expertise.
Presenters:
John Owen, Head of Partnerships and Development, CDISC