Page History
...
| Category | Standards for Collection | Standards for Tabulation | Standards for Analysis |
|---|---|---|---|
| Product Description | Study Data Tabulation Model (SDTM) | Analysis Data Model (ADaM) | |
| Nonclinical | Study Data Tabulation Model (SDTM) | ||
| Product Impact on Individual Health | Clinical Data Acquisition Standards Harmonization (CDASH) | Study Data Tabulation Model (SDTM) | Analysis Data Model (ADaM) |
| Product Impact on Population Health | Analysis Data Model (ADaM) |
SDTM
Observations about study subjects are normally collected for all subjects in a series of domains. A domain is defined as a collection of logically related observations with a common topic. The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial. Each domain is represented by a single dataset.
Each domain dataset is distinguished by a unique, 2-character code that should be used consistently throughout the submission. This code, which is stored in the SDTM variable named DOMAIN, is used in 4 ways: as the dataset name, as the value of the DOMAIN variable in that dataset, as a prefix for most variable names in that dataset, and as a value in the RDOMAIN variable in relationship tables (see Section 8, Representing Relationships and Data).
All
...
All models implemented as part of this guide collect and represent data by common topics with:
- CDASH and SDTM grouping logically related data points in domains; and
- ADaM dataset design customizable to support analysis requirements.
...
Overview
Content Tools