Date and Time:
TUE, 21 APR 2020, 11:00 AM - 11:30 AM Eastern US Standard Time
Description:
Learn about the CDISC CDASH SAE Project, which will update CDASH SAE Supplement v1.0 to be aligned with the 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 and templates. The CDASH SAE Supplement v2.0 will expand AE and other domains in CDASH 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.
Presenter:
John Owen, CDISC Senior Project Manager
Webinar Language: English
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