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TIG v1.0 provides specific domain models, assumptions, business rules, and examples for preparing standard data collection, tabulation datasets, and analysis datasets that are based on the CDASH, SDTM, ADaM, and Analysis Results models respectively. This document is intended for companies and individuals involved in the collection, preparation, and analysis of product description, non-clinical, and clinical data that will be submitted to regulatory authorities. The TIG should be used in close concert with:

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).

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• Version 1.2 of the CDISC Clinical Data Acquisition Standards Harmonization (CDASH, available at https://www.cdisc.org/standards/foundational/cdash/cdash-model-v1-2), provides a general framework for creating fields to collect information on CRFs and includes the model metadata, which shows the standard variables in the model.
• Version 2.0 of the CDISC Study Data Tabulation Model (SDTM, available at

• https://www.cdisc.org/standards/

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• foundational/

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• sdtm), which describes the general conceptual model for representing clinical study data that is submitted to regulatory authorities.
• Version 2.1 of the CDISC Analysis Data Model (ADaM, availble at ), which describes...
• Version TBD of the Analysis Results Model... 
• Version 2.0 ODM-XML
• Version 1.0 Lab-XML
• Version 2.1 Define-XML...