This publication aims to clearly define the relationships between published CT codelists/terminology subsets and the CDISC variables, tests, parameters, and non-standard variables (NSVs) published in SDTM v1.7, SDTMIG v3.3, SDTMIG-MD v1.1, CDISC Therapeutic Area User Guides, and regulatory documents. Currently, CDISC CT is updated biannually, while the Model, Implementation Guides, and User Guides are updated less frequently. Additionally, information related to terminology usage is often dispersed across multiple documents. The objective of this publication is to provide a single, explicit, and comprehensive view of Controlled Terminology usage within clinical data tabulation activities.
Highlights
- Aligns with SDTM CT Package 58 from 2024-09-27
- Contains 2,384 rows of Controlled Terminology relationship metadata, including, not limited to:
- 7 classes and 65 SDTMIG domains
- 762 SDTM/SDTMIG variables
- 97 SuppQuals (non-standard variables)
- 148 external dictionary requirements from 35 dictionaries from 22 organizations
- Includes where, and details what, allowed subset of value(s) from CDISC Controlled Terminology are applicable
- Indicates, where applicable, additional terminologies requirements for data submission to regulatory agencies (US FDA, Japan PMDA, China NMPA, EMA)
- Specifies the Define-XML data type for responses to tests and parameters in applicable SDTM domains
- Includes JSON and YAML files (machine-readable formats, with hyperlinks to CDISC Library) to enhance process automation
Use Cases
- Improve process automation to create Trial Design datasets for regulatory submissions
- Streamlines input to data validation software for additional terminologies requirements for regulatory submissions
- Enables data to comply to Controlled Terminology requirements upfront, providing inherit high-quality data at SDTM dataset generation
- Enables software integration with CDISC Library
Note: The Read Me provides column descriptions in the Controlled Terminology Relationships tables for SDTM v1.7, SDTMIG v3.3, and SDTMIG-MD v1.1. 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.