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The scientific subject matter of the data and related activities such as data collection, data tabulation, data analysis, and data exchange drive which standards to implement. Implementation of standards starts with determining which standards are appropriate based on the nature of the data and activities to be supported. After standards are selected, it is then possible to determine how the data are collected, represented, or exchanged using the standards. 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 in this guide are aligned with both use cases and activities. Given this, determining which standards to use may begin by selecting standards for the use case and activity to be supported. It is recommended that all TIG guidance is reviewed, both general and detailed, prior to implementing standards. For ease of use, the table below presents use cases, activities, and corresponding sections in this guide which provide detailed instructions for implementation. Detailed instructions referenced are:

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Most product-level and subject-level observations collected during the  should be represented according to 1 of the 3 SDTM general observation classes: Interventions, Events, or Findings. 

Standards for collection and tabulation collect and represent data using groupings of logically related data called domains. 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 organized in relation to analysis requirements with the structure of tabulation datasets facilitating the generation of analysis datasets.

Custom domains and corresponding specifications must be created based on the three general observation classes, Interventions, Events, and Findings, described in the SDTM

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 using 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 organized in relation to analysis requirements with the structure of tabulation datasets facilitating the generation of analysis datasets.

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