The TIG provides guidance for how to use CDISC standards for the collection and representation of tobacco product study data. Standards in this guide are applicable to use cases inherent to studies of tobacco products. Use cases covered in this guide present concepts identified by one or more stakeholders as important in the context of tobacco product studies:
Introduction text needed
- guidance on the use of domains and variables; and
- sample annotated case report forms (aCRFs);
- examples of SEND and SDTM datasets, with text describing the situational context and pointing out records of note; and
- guidance on the use of ADaM and other analysis datasets
Overview
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