Page History

This document guide is organized into the following sections:

• Section 1, Introduction, provides an overall introduction to the v3.4 models and describes changes from prior versions.Section 2, Fundamentals of the SDTM (Copy), recaps the basic concepts of the SDTM, and describes how this implementation guide should be used in concert with the SDTM.
• Section 3, Submitting Data in Standard Format (Copy), explains how to describe metadata for regulatory submissions, and how to assess conformance with the standards.
• Section 4, Assumptions for Domain Models (Copy), describes basic concepts, business rules, and assumptions that should be taken into consideration before applying the domain models.
• Section 5, Models for Special-purpose Domains (Copy), describes special-purpose domains, including Demographics, Comments, Subject Visits, and Subject Elements.
• Section 6, Domain Models Based on the General Observation Classes (Copy), provides specific metadata models based on the 3 general observation classes, along with assumptions and example data.
• Section 7, Trial Design Model Datasets (Copy), describes domains for trial-level data, with assumptions and examples.
• Section 8, Representing Relationships and Data (Copy), describes how to represent relationships between separate domains, datasets, and/or records, and provides information to help sponsors determine where data belong in the SDTM.
• Section 9, Study References (Copy), provides structures for representing study-specific terminology used in subject data.
• guide describing its purpose, organization, and relationship to other CDISC standards and resources.
• Section 2, Standards for Tobacco Product Data, describes how to use CDISC standards and resources for the collection, representation, and exchange of tobacco product data.
• Section 3, Examples, provides examples to demonstrate the intended use of CDISC standards for tobacco product data.
• Appendices provide additional background material and other supplemental material to support implementationAppendices (Copy) provide additional background material and describe other supplemental material relevant to implementation.