Page History

...

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 (Copy), 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.

...