Comments Due By
CDISC invites you to submit comments on the draft version 1.3 of the CDASH Model and version 2.3 of the CDASH Implementation Guide (IG) during Public Review.
The most significant changes from the previous versions include:
- Additional SDTMIG v3.3 domains (i.e., CV, MK, NV, UR).
- SDTMIG v3.4 domains (i.e., GF, CP).
- SA domain and variables from the SAE Supplement v2.0.
- Changes to CDASHIG and CDASH Model variable labels, where needed, to more closely align with SDTMIG and SDTM variable labels.
- Updated HO domain date/time prompts to include HOTERM as an optional element.
- "Regulations" in definition and CRF Completion Guidelines for AESER variable.
- Administrative updates that may include metadata consistency to standardize variable definitions across domains.
To Provide Comments:
- View the Draft Documents: CDASH Model v1.3 and CDASHIG v2.3
- NEW! View Draft Metadata: CDASH Model v1.3 and CDASHIG v2.3 draft metadata is available in CDISC Library so that you can review this content with the Data Standards Browser or test in your systems via the API. Access to CDISC Library, the authoritative source of CDISC standards metadata, is free to members and non-members. Sign in or Sign Up for a cdiscID, which allows Single Sign-On to CDISC Library, the CDISC website, and the CDISC Learning System.
- Instructions for Reviewers.
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 cdiscID .
Public review is a key quality step in our Standards Development Process. 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.
Thank you for contributing your time and expertise.