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Standard Models
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:
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- Version
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- 1.2
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- of the CDISC Clinical Data Acquisition Standards Harmonization (CDASH
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- ), which provides a general framework for creating fields to collect information on Case Report Forms (CRFs).
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- Version 2.0
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- of the CDISC Study Data Tabulation Model (SDTM
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- , available at https://www.cdisc.org/standards/foundational/sdtm
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- ), which provides a standard model for study data tabulations.
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- Version 2.1
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- of the CDISC Analysis Data Model (ADaM
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- , available at https://www.cdisc.org/standards/foundational/adam
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- ) which specifies the principles and standards to follow in the creation of analysis datasets and associated metadata.
Additional Standards and Resources
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- CDISC Controlled Terminology (available at https://www.cdisc.org/standards/terminology/controlled-terminology), which provides consistent semantics for use across standards.
- Conformance rules ... for tabulation and analysis standards (reference needed)
- Standards and tools for data exchange:
- The 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.
- Educational Materials (reference needed)
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