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CDISC models used to standardize data collection, data tabulation, and creation of analysis datasets are implemented with purpose in mind. This section guides the selection of standards to used based on:

to guide the selection of standards to use based on the data to be collected and represented.

• Tobacco product study use cases covered in this guide.
• The purpose of a standard model in relation to these use cases.

The table below relates use cases to models implemented in the TIGCDISC models used to standardize data collection, data tabulation, and creation of analysis datasets are implemented with purpose in mind.

CDASH:

Throughout this document, a deliberate decision was made to use a variety of synonyms for various terms in order to reflect the fact that sponsors also use a variety of terms.

• Paper CRFs vs. electronic CRFs: The term CRF used throughout this document refers to both paper and electronic formats, unless otherwise specified.
• Fields vs. variables: Data collection fields refers to terms that are commonly on the CRF. Data collection variables refers to what is in a clinical database.
• Study treatment: The phrase study treatment has been used instead of investigational/medicinal product, study drug, test article, vaccine, study product, medical device, and so on, in order to include all types of study designs and products.
• Mechanisms for data collection: Different data-collection mechanisms can be used to control how data are collected (e.g., tick boxes, checkboxes, radio buttons, drop-down lists). For the purposes of this document, these terms are used interchangeably.

Subjects are... Note that generally the term "trial" is equivalent to "study" in the nonclinical context. In addition, "subjects" are equivalent to "animals."

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