Controlled Terminology Relationships v1.0 (SDTM v1.7/SDTMIG v3.3/SDTMIG-MD v1.1)

Comments Due By


CDISC is pleased to announce version 1.0 of the CT Relationships for SDTM v1.7/SDTMIG v3.3/SDTMIG-MD v1.1 is entering the Public Review period to solicit your feedback.

This work seeks to explicitly show the relationships between published Controlled Terminology codelists/terminology subsets and those CDISC variables, Tests, Parameters, and NSVs that are published in SDTM v1.7, SDTMIG v3.3, SDTMIG-MD v1.1, CDISC Therapeutic Area User Guides, and regulatory documents. Currently, CDISC CT updates on a quarterly basis while the Model, Implementation Guides, and User Guides update less frequently. Additionally, different information pertaining to terminology usage may appear across multiple documents. The purpose of this project is to create a singular, explicit, and complete view of Controlled Terminology usage across clinical data tabulation activities.

View the draft: CT Relationships for SDTM v1.7/SDTMIG v3.3/SDTMIG-MD v1.1

Instructions for providing comments: Instructions for Reviewers

Public Review closes 31 October 2023.

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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.