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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 documents to describe datasets. Standards referenced in this section are supported by the CDISC Operational Data Model (ODM, available at https://www.cdisc.org/standards/data-exchange/odm). ODM 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 (https://www.cdisc.org/kb/ecrf) is a platform from which to download standard CRFs including metadata standardized per ODM. All example CRFs in Section 3.3, Product Impact on Individual Health, may be downloaded in ODM format and loaded into applicable EDC tools. Once loaded into an EDC tool, standard CRFs may then be used as-is or modified per the TIG and related CDISC standards to support needs.

CDISC Library

The CDISC Library (https://www.cdisc.org/cdisc-library) is a free community resource from which TIG v1.0 standards may be browsed, searched, and downloaded for electronic use. The Library is a cloud-based Metadata Repository (MDR) used to support efficient and controlled development, management, reuse, and electronic publication of all applicable CDISC standards. It consolidates standards within a single user interface and enables the export of standards in multiple formats for ease of implementation into software solutions. Additionally, the Library can be accessed via an API to deliver CDISC standards metadata to software applications that automate standards-based processes.

Creating Data Definition Documents to Support Data Submission

Version 2.1 of the CDISC Define-XML standard (available at https://www.cdisc.org/standards/data-exchange/define-xml/) supports creation of data-definition files which describe the structure and contents of tabulation and analysis datasets. Define-XML documents provide both a machine-readable format for use by various software applications and, through the provision of an XSL stylesheet, a browser-based rendition describing the metadata attributes of tabulation and analysis datasets. The Define-XML model is implemented using extensions to the ODM-XML schema.

SEND - test names greater than 40 characters

Sponsors may have test descriptions (--TEST) longer than 40 characters in their operational databases. Because the --TEST variable is meant to serve as a label for --TESTCD when a Findings dataset is transposed to a horizontal format, the length of --TEST is normally limited to 40 characters to conform to the limitations of the SAS v5 transport file format currently used for submission datasets. Therefore, sponsors have the choice to either insert the first 40 characters or a text string abbreviated to 40 characters in --TEST. To address this issue, sponsors may include the full description for these variables:

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