CDASH Serious Adverse Event Supplement 2.0

Comments Due By

CDISC invites you to provide comments on version 2.0 of the CDASH Serious Adverse Event (SAE) Supplement during Public Review.

The CDASH SAE Supplement v2.0 captures how to structure SAE concepts for regulated clinical trials and aligns with E2B (R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide – Data Elements and Message Specification. It is an update to CDASH SAE Supplement v1.0, released in 2013.

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Public review is a key quality step in our Standards Development Process. Thank you for contributing your time and expertise. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.