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.
- CDISC Library (available...)
- 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.
- Educational materials, (available at <placeholder, link pending>), to support understanding and use of the TIG v1.0.
Approaches to
- Text was leveraged to develop the TIG.
- TIG is a free-standing guide that is not inherently related or dependent on those standards.
Overview
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