The SDTM provides a general framework for describing the organization of information collected during human and nonclinical studies. The model is built around the concept of observations, which consist of discrete pieces of information collected during a study. Observations normally correspond to rows in a dataset. A domain is a collection of observations on a particular topic (see Concept Map, below). For example, "Subject 101 had an adverse event of mild nausea starting on study day 6" is an observation belonging to the Adverse Events domain in a clinical trial.
The primary purpose of the SDTM is to represent data about study subjects (e.g., humans, animals, medical devices). The SDTM includes a general model for representing data in 3 "general observation" classes. Within those classes, data are grouped by topic into domains, represented in separate datasets. The 3 general observation classes (i.e., Interventions, Events, Findings) are described further in Section 3.1, The General Observation Classes. Additional special-purpose datasets about individuals are described in Section 3.2, Special-purpose Domains.
Studies sometimes include data about "associated persons" who are not study subjects; these data are represented in domains based on the domains used to represent data about study subjects. The structure of these domains is described in Section 4, Associated Persons Data.
The SDTM includes a set of tables for representing data at the study level. These datasets are specified in Section 5, Study-level Data.
The last group of datasets in the SDTM are those that describe relationships among datasets and records. These datasets are specified in Section 6, Datasets for Representing Relationships.
Concept Map. Relationships Between SDTM Domains
Overview
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