sdtm-explorer

SDTM Explorer

About the tool

The Structured Data Transformation Model (SDTM) is a standard for the structure and content of clinical trial tabulation datasets that are submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).

This tool is an interactive browser for the SDTM data model that displays the polyhierarchy of SDTM classes and domains as a tree. You can browse the attributes of each class and view their descriptions by clicking on the purple links. The structure of classes is rendered as a TypeScript-like type definition. You can navigate to the referenced classes by following the blue links.

Demo

Associated persons are individuals other than study subjects who can be associated with a study, a particular study subject, or a device used in the study. The structures of SDTM datasets that represent data about associated persons are based on the structures for data about study subjects, either general observation class structures or special-purpose domain structures. AP domains are created using SDTM variables, with the application of specific AP rules. (Source: SDTM v2.0, Section 4)

This SDTM class provides a means to link related records between datasets. It includes the RELREC and SUPPQUAL datasets. (Source: CDISC Controlled Terminology, GNRLOBSC, RELATIONSHIP, 2021-09-24)

Start with selecting a table from the list.

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