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.
To provide comments:
- View the draft: CDASH SAE Supplement v2.0 .
- Instructions for providing comments: Instructions for Reviewers
- CDISC will be hosting a Public Review webinar 10 November 11 am - 12:30 pm EST. REGISTER NOW
You will need to log in or register for the CDISC Wiki to provide comments.
- Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org
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.