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Standards for data exchange support sharing of structured metadata and data between parties and across different information systems. Standards referenced in this section support exchange of CDASH compliant CRFs for data collection and exchange of tabulation and analysis datasets through provision of data definition files to describe datasets. Standards referenced in this section are supported by the CDISC Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm). ODM-XML is a vendor-neutral, platform-independent format for exchanging and archiving research data, along with their associated metadata, administrative data, reference data, and audit information.


Accessing CDASH Compliant CRFs 

The CDISC eCRF Portal (available at https://www.cdisc.org/kb/ecrf) is a platform from which to download standard CRFs including metadata standardized per ODM-XML. All example CRFs in Examples Section x.x, Product Impact on Individual Health, may be downloaded in ODM-XML format and loaded into applicable electronic data capture (EDC) tools. Once loaded into an EDC tool, standard CRFs may then be used as-is or modified per CDISC standards to support needs.


Creating Data Definition Files to Support Data Submission

The CDISC Define-XML Model Versupports creation of data definition files with which to describe the structure and contents of tabulation and analysis datasets. The Define-XML Model provides both a machine-readable format for use by various software applications and, through the provision of an XSL stylesheet, a browser-based report describing the metadata attributes of tabulation and analysis datasets. The Define-XML Model is an extension of the ODM-XML Model.


The Define-XML standard (available at https://www.cdisc.org/standards/data-exchange/define-xml) specifies metadata attributes to describe SDTM data. Need Version


SDTM 2.2 Datasets and Domains 

Each dataset is described by metadata definitions that provide information about the variables used in the dataset. The metadata are described in a data definition document (i.e., a Define-XML document) that is submitted with the data to regulatory authorities. 

  1. See the SDTM Define-XML specification (https://www.cdisc.org/standards/data-exchange/define-xml) for details regarding metadata representation when a domain is split into different datasets.

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