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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 in the TIG starts with the selection of standards to use 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.

In the TIG this guide, selection of standards begins with the use case to use may begin with  be addressed and activities to be supported. Standards in this guide are organized by both use cases and activities. Use cases and activities are show in the table below 

At the highest level, use cases addressed in the TIG are aligned with data-related activities supported by the standards. use cases inherent to studies of tobacco productsboth tobacco study use cases and by data related processes they support. In the TIG:  

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Use cases, activities, and associated sets of standards in scope for this guide are shown in the table below.

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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. 

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