This document 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, 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, explains how to describe metadata for regulatory submissions, and how to assess conformance with the standards.
- Section 4, Assumptions for Domain Models, 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, describes special-purpose domains, including Demographics, Comments, Subject Visits, and Subject Elements.
- Section 6, Domain Models Based on the General Observation Classes, provides specific metadata models based on the 3 general observation classes, along with assumptions and example data.
- Section 7, Trial Design Model Datasets, describes domains for trial-level data, with assumptions and examples.
- Section 8, Representing Relationships and Data, 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, provides structures for representing study-specific terminology used in subject data.
- Appendices provide additional background material and describe other supplemental material relevant to implementation.
Overview
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