CDASH SAE Supplement v2.0

Published Date:

Version 2.0 of the CDASH SAE Supplement captures how to structure serious adverse events (SAE) concepts for regulated clinical trials. It also aligns with E2B (R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide – Data Elements and Message Specification and brings the standard up to date with current CDISC standards.

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.

TransCelerate Biopharma led The Common SAE Fields Initiative, which was designed to increase the quality and comprehensiveness of SAE reports. The Initiative focused on the assessment of the common core fields collected and reported following an SAE. Upon completion of this assessment, TransCelerate Biopharma proposed a list of SAE fields that would better support a complete clinical picture of an SAE. Project deliverables were transitioned to CDISC to create a global, industry standard for collecting data at the onset of an SAE.
Public Review Comments

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