This guide describes how to implement CDISC models to standardize collection and representation 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 CRFs and includes the model metadata, which shows the standard variables in the model.
- 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 fundamental principles and standards to follow in the creation of analysis datasets and associated metadata.
This guide also references
- Version 1.0 Lab-XML (Placeholder - This is not a model. Updates to text pending.)
- Version 2.0 ODM-XML (Placeholder)
- Version 2.1 Define-XML. (Placeholder)
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