CDISC CDASH SAE Supplement v2.0 Released

On 21 April 2021 the CDISC announced the release of the CDASH SAE Supplement version 2.0.

Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the release of version 2.0 of the CDASH SAE Supplement, which is now freely available on CDISC’s website. CDASH SAE Supplement v2.0 captures how to structure serious adverse events (SAE) concepts for clinical trials and is aligned with E2B (R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide – Data Elements and Message Specification

The CDASH SAE Supplement v2.0 expands AE and other domains from the CDASH Model v1.1 and its Implementation Guide, CDASHIG v2.1 as well as Controlled Terminology to include additional data elements that capture information in an SAE form, facilitating Sponsor generation of an E2B message for reporting of an ICSR to regulatory authorities.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /