CDISC invites you to submit comments on version 1.0 of the Controlled Terminology relationships for SDTM v1.4 and SDTMIG v3.2 during Public Review.
Please note: The Read Me file provides column descriptions in the Controlled Terminology Relationships tables for SDTM v1.4 and SDTMIG v3.2. These tables show the relationships between published variables and CDISC Controlled Terminology. In addition to Controlled Terminology, references are provided for MedDRA and other external dictionaries.
The primary purpose of this content is to explicitly document relationships between SDTMIG v3.2 variables and terminology requirements (CDISC Controlled Terminology, external dictionaries, etc.).
We are soliciting comments for the inclusion of Non-Standard Variables (NSV) from Therapeutic Area User Guides (TAUG) with associated terminology. For Public Review, only a sample of TAUG publications that implement SDTMIG v3.2 are included. Review comments will inform the team if further content development pertains to the user community’s interests.
To Provide Comments:
- View the Draft: Controlled Terminology Relationships for SDTM v1.4 and SDTMIG v3.2
- Instructions for providing comments: 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 www.cdisc.org.
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.