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This document, together with the SDTM, represents the most recent version of the CDISC submission data domain models. All updates are intended to be backward-compatible. The most significant changes since SDTMIG v3.3 include:

  • Expanded the scope of the DA domain to include study products in addition to study drugs. See Section 6.3.1, Product Accountability.
  • Grouped specimen-based lab domains (e.g., CP, GF, LB) in Sections 6.3.5.1-6.3.5.9 and added a generic specification for these domains. See Section 6.3.5, Specimen-based Findings Domains (Copy).
  • Expanded the scope of the IS domain for assessments of antigen-induced humoral or cell-mediated immune response. Added 3 new variables (i.e., Binding Agent, Molecule Secreted by Cells, Test Operational Objective). See Section 6.3.5.5, Immunogenicity Specimen Assessments.
  • Updated the LB domain specification to include the following 10 new variables: Test Condition, Binding Agent, Test Operational Objective, Result Scale, Result Type, Collected Summary Result Type, Lower Limit of Detection, Method Sensitivity, Point in Time Flag, and Planned Duration. See Section 6.3.5.6, Laboratory Test Results.
  • Decommissioned the Morphology (MO) domain.
  • Added Cell Phenotyping Findings (CP) and Genomics Findings (GF) domains. See Section 6.3.5.3, Cell Phenotype Findings (CP) (Copy), and Section 6.3.5.4, Genomics Findings (GF) (Copy).
  • Copied in Biospecimen Events (BE), Biospecimen Findings (BS), and Related Specimens (RELSPEC) from the provisional SDTMIG-PGx v1.0 in preparation for its eventual retirement. See Section 6.2.2, Biospecimen Events (BE) (Copy); Section 6.3.5.2, Biospecimen Findings (BS) (Copy); and Section 8.8, Related Specimens (RELSPEC) (Copy).
  • Updated QRS specifications and assumptions. Also introduced subsections to separate assumptions and examples describing the RS Disease Response use case and the RS Clinical Classifications use case. See Section 6.3.9, Questionnaires, Ratings, and Scales (QRS) Domains (FT, QS, RS) (Copy).
  • Updated the Tumor/Lesion (TU and TR) domain assumptions to describe use of indicator questions, disease recurrence conventions, and modeling of location of interest. See Section 6.3.12, Tumor/Lesion Domains (Copy).
  • Expanded the scope of the SC domain to support collection over time. See Section 6.3.10, Subject Characteristics.
  • Updated guidance and examples for the FA domain. See Section 6.4, Findings About Events or Interventions (Copy).
  • Corrected Core values for the following variables: DSDY, DSSTDY, LBSTREFC, MILOBXFL, and MIBLFL.
  • Updated Controlled Terminology for applicable variables across all domains, if available.
  • Removed Appendix C1, Trial Summary Codes.

A detailed list of changes between versions is provided in Appendix E, Revision History (Copy).

Version 3.1 was the first fully implementation-ready version of the CDISC submission data standards that was directly referenced by the US FDA for use in human clinical studies involving drug products. However, future improvements and enhancements will continue to be made as sponsors gain more experience submitting data in this format. Therefore, CDISC will be preparing regular updates to the implementation guide to provide corrections, clarifications, additional domain models, examples, business rules, and conventions for using the standard domain models. Because CDISC will produce further documentation for Controlled Terminology as separate publications, sponsors are encouraged to check the CDISC website (https://www.cdisc.org/standards/terminology/controlled-terminology) frequently for additional information. See Section 4.3, Coding and Controlled Terminology Assumptions (Copy), for the most up-to-date information on applying Controlled Terminology.

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