Version 1.0 of the Controlled Terminology Relationships for SDTM v1.4 and SDTMIG v3.2 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 v1.4, SDTMIG v3.2, Therapeutic Area User Guides, and regulatory documents.
CDISC Controlled Terminology is released quarterly while CDISC Foundational Standards and Therapeutic Area User Guides are published less frequently. Different information pertaining to Controlled Terminology usage may appear across multiple documents. Controlled Terminology Relationships v1.0 for SDTM v1.4 and SDTMIG v3.2 provides first-of-its-kind content to create a singular, explicit, and complete view of Controlled Terminology across clinical data tabulation activities.
- Aligns with SDTM CT Package 45 from 2021-03-26
- Contains 766 rows of Controlled Terminology relationship metadata, including, not limited to:
- 7 classes and 46 SDTMIG domains
- 588 SDTM/SDTMIG variables
- SuppQuals (non-standard variables) from 21 TAUGs
- 106 external dictionary requirements from 21 dictionaries from 16 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)
- Comprises an Excel spreadsheet and a YAML file (machine-readable format, with hyperlinks to CDISC Library)
- 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 tab in the document 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.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.