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Standards in this guide are end-to-end implementations of CDISC models which are designed to ensure the traceability and transparency of data across activities in the data lifecycle. Implementation of models per this guide with relationships across activities is further described in the table below.

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CDASH Model

• In this guide, the CDASH Model is implemented to support development of CRFs for the Product Impact on Individual Health use case. The CDASH Model is the earliest model implemented for this use case.
• The CDASH Model defines a basic set of data collection fields that are expected to be present on the majority of CRFs.
• The use of CDASH data collection fields and variables is intended to facilitate mapping to datasets implemented  SDTM structure. When submitted data can be collected as represented in an SDTM dataset, with no transformations or derivations, the SDTMIG variable names are presented in the CDASHIG metadata table and should be used to collect the data. In cases where the collected data must be transformed or reformatted prior to inclusion in an SDTM dataset, or where a corresponding SDTMIG variable does not exist, CDASH has created standardized data collection variable names. 

SDTM

• The SDTM is implemented for use cases

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. The TIG provides instructions and recommendations to implement these models for the collection, representation, and exchange of tobacco product data. Controlled terminology and formats support implementation of all models. Standards for data exchange are applicable to all use cases and allow for the exchange of metadata for CRFs, tabulation datasets, and analysis datasets. 

The following table describes implementation of CDISC models with supporting standards and TIG sections.