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Domains

CDASH:

Throughout this document, a deliberate decision was made to use a variety of synonyms for various terms in order to reflect the fact that sponsors also use a variety of terms.

• Paper CRFs vs. electronic CRFs: The term CRF used throughout this document refers to both paper and electronic formats, unless otherwise specified.
• Fields vs. variables: Data collection fields refers to terms that are commonly on the CRF. Data collection variables refers to what is in a clinical database.
• Study treatment: The phrase study treatment has been used instead of investigational/medicinal product, study drug, test article, vaccine, study product, medical device, and so on, in order to include all types of study designs and products.
• Mechanisms for data collection: Different data-collection mechanisms can be used to control how data are collected (e.g., tick boxes, checkboxes, radio buttons, drop-down lists). For the purposes of this document, these terms are used interchangeably.

Subjects are... Note that generally the term "trial" is equivalent to "study" in the nonclinical context. In addition, "subjects" are equivalent to "animals."

Values in this column should be used with values in TIG Core to determine when a field should be present on a CRF. 

How collection, tabulation, and analysis standards are related.

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.

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