Relationship to CDISC Standards and Resources

The TIG guides implementation of CDISC models to standardize collection and 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.

The TIG also references additional standards and resources to support implementation:

• CDISC Controlled Terminology (available at https://www.cdisc.org/standards/terminology/controlled-terminology), which provides consistent semantics for use across standards.
• CDISC QRS Supplements (available at https://www.cdisc.org/foundational/qrs), which provide information on how to structure the data in a standard format for public domain and copyright-approved instruments.
• Version 1.0 of the CDISC TIG Conformance rules (available at <placeholder, link pending>), with which to assess tabulation and analysis datasets conformance to TIG standards.
• CDISC eCRF Portal (available at https://www.cdisc.org/kb/ecrf) and Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm), which provide a platform from which to download standard CRFs including metadata standardized per ODM-XML. ODM-XML is a standard, 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.
    • Define is a model
• Educational Materials (reference needed)