CDISC, with support from our partner TransCelerate Biopharma, is developing version 2.0 of the CDASH SAE Supplement, an update to CDASH SAE Supplement v1.0, released in 2013. CDASH SAE Supplement v2.0 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.
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.
CDISC will develop the standard with SAE and safety operations experts from the TransCelerate Initiative.
Project goals include:
- Expanding AE and other CDASH domains to include additional data elements to capture information in an SAE form, facilitating Sponsor generation of an E2B message for electronic reporting of an ICSR to regulatory authorities.
- Ensuring alignment with CDASH and SDTM for electronic submissions.
- Coding applicable SAE reporting concepts related to prevention and diagnostic concepts and Controlled Terminology in the NCI EVS terminology system.
- Using CDISC Library and other CDISC Tools to support the update process.
- Providing machine-readable content of the standard in CDISC Library.
Public Review is estimated to take place Q3 of 2020, with an anticipated publication in 2021. Once published, CDASH-SAE Supplement v2.0 will be freely available on the CDISC website.
For updated information on the progress of the project, please visit Standards in Development.