Page History

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 standard CDASH compliant CRFs for data collection and exchange of tabulation and analysis datasets through provision of data definition files to describe shared datasets.  Standards Standards referenced in this section are based on supported by the CDISC Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm). ODM-XML is a standard, vendor-neutral, platform-independent format  add more text herefor 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 Section 

ODM-XML is a standard, vendor-neutral, platform-independent format for representing and exchanging CRF content in electronic data capture (EDC) tools .which enables 

Creating Data Definition Files to Support Data Submission

The CDISC Define-XML Model supports 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.

...