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Observations and Variables - SDTMIG v3.4 - Wiki (cdisc.org) The SDTMIG for Human Clinical Trials is based on the SDTM’s general framework for organizing clinical trial information that is to be submitted to regulatory authorities. The SDTM is built around the concept of observations collected about subjects who participated in a clinical study. Each observation can be described by a series of variables, corresponding to a row in a dataset. 

Datasets and Domains - SDTMIG v3.4 - Wiki (cdisc.org)

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.

Determining Where Data Belong

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