Page History

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• 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 the following CDISC standards to support data exchange:

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• 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 case report form 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.
• 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 ODM-XML, ODM-XML is a vendor-neutral, platform-independent format for exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information. ODM-XML facilitates the regulatory-compliant acquisition, archival and exchange of metadata and data. It has become the language of choice for representing case report form content in many electronic data capture (EDC) toolsVersion 2.1 Define-XML. (Placeholder)