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Once standards are selected based on the use case and activity, the scientific subject matter of the data, its role, and analysis needs will determine where data belong, i.e., how the data are collected, represented, or exchanged using the standards. Standards for collection and tabulation collect and represent data in groupings of logically related data called domains. Domains are aligned between collection and tabulation standards to facilitate the transition of collected observations to their representation in tabulation datasets. Standards for analysis are aligned with based on analysis requirements with the structure of tabulation datasets facilitating the generation of analysis datasets.

To use standards for collection and tabulation, compare the nature or role of the data to the scope of  where of a domain. A domain standard may be used when the nature of the data must be within and the domain scope are aligned. Observations will be collected using collection standards and represented as rows in tabulation datasets. Each observation is described by a series of a domain for the domain to be used.data points which correspond to data collection fields and columns in a tabulation dataset.




Fields and variables may be used when 

To use standards for analysis, 




Observations are described using collection and tabulation variables. 







are used to design customized datasets is cucustomizable per analysis requirements.

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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)

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