Page History

Resources are available to support implementation of data standards per this guide.

CDISC Models

The TIG guide describes how to implement CDISC models to standardize collection, representation, and exchange of tobacco product study data. The CDISC models implemented in this guide are:

• Version 1.2 of the CDISC Clinical Data Acquisition Standards Harmonization (CDASH, available at https://www.cdisc.org/standards/foundational/cdash/cdash-model-v1-2), which provides a general framework for creating fields to collect information on Case Report Forms (CRFs).
• Version 2.0 of the CDISC Study Data Tabulation Model (SDTM, available at https://www.cdisc.org/standards/foundational/sdtm), which provides a standard model for study data tabulations.
• Version 2.1 of the CDISC Analysis Data Model (ADaM, available at https://www.cdisc.org/standards/foundational/adam) which specifies the principles and standards to follow in the creation of analysis datasets and associated metadata.

Support for Data Exchange

This guide also references the following CDISC tools and standards to support data exchange:

• eCRF Portal
• Version 2.0 of the CDISC Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm), which provides a vendor-neutral, platform-independent format for representing and exchanging CRF content in electronic data capture (EDC) tools.
• Version 2.1 of the CDISC Define-XML (Define-XML, available at https://www.cdisc.org/standards/data-exchange/define-xml/define-xml-v2-1), which provides a metadata standard used to describe any tabular dataset structure.

Conformance Rules

Education