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  1. This 
  2. First, read the foundational standards upon which this document is based—CDASHIG v2.1, CDASH Model v1.1, SDTM v1.7 and the SDTM Implementation Guides (SDTMIG v3.3,  SDTMIG-MD v1.1, and SDTMIG-AP v1.0)—to gain some familiarity with data models and the basic rules for how they are implemented. These standards are available at: http://www.cdisc.org/.
  3. Next, read Introduction to Therapeutic Area Standards and/or take CDISC's free training module TA001 - Overview of Therapeutic Area User Guides for an understanding of what to expect from this guide. 
  4. Read this guide all the way through (without skipping any sections) at least once.
  5. Finally, revisit any sections of particular interest.







The SDTMIG is best read online, so the reader can benefit from the many hyperlinks to internal and external references. The following guidelines may be helpful in reading this document:

  1. First, read the SDTM to gain a general understanding of SDTM concepts.
  2. Next, read Sections 1-3 of this document to review the key concepts for preparing domains and submitting data to regulatory authorities. Refer to Appendix B, Glossary and Abbreviations, as necessary.
  3. Read Section 4, Assumptions for Domain Models (Copy). 
  4. Review Section 5, Models for Special-purpose Domains (Copy), and Section 6, Domain Models Based on the General Observation Classes (Copy), in detail, referring back to Section 4, Assumptions for Domain Models (Copy), as directed. See the implementation examples for each domain to gain an understanding of how to apply the domain models for specific types of data.
  5. Read Section 7, Trial Design Model Datasets (Copy), to understand the fundamentals of the Trial Design Model and consider how to apply the concepts for typical protocols.
  6. Review Section 8, Representing Relationships and Data (Copy), to learn advanced concepts of how to express relationships between datasets, records, and additional variables not specifically defined in the models.
  7. Review Section 9, Study References (Copy), to learn about occasions when it is necessary to establish study-specific references that will be used in accordance with subject data.
  8. Finally, review the appendices as appropriate. Appendix C, Controlled Terminology, in particular, describes how CDISC Terminology is centrally managed by the CDISC Controlled Terminology Team. Efforts are made at publication time to ensure all SDTMIG domain/dataset specification tables and/or examples reflect the latest CDISC Terminology; users, however, should refer to https://www.cancer.gov/research/resources/terminology/cdisc as the authoritative source of controlled terminology, as CDISC Controlled Terminology is updated on a quarterly basis.

This implementation guide covers most data collected in human clinical trials, but separate implementation guides provide information about certain data, and should be consulted when needed. The following guides are available at https://www.cdisc.org/standards/foundational/sdtmig:

  • The SDTM Implementation Guide: Associated Persons (SDTMIG-AP) provides structures for representing data collected about persons who are not study subjects.
  • The SDTM Implementation Guide for Medical Devices (SDTMIG-MD) provides structures for data about devices.
  • Historically, the SDTM Implementation Guide for Pharmacogenomics/Genetics (SDTMIG-PGx) has provided structures for pharmacogenetic/genomic data and for data about biospecimens. Much of the content of the SDTMIG-PGx has been incorporated into and/or superseded by the SDTMIG v3.4.

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