FDA CDER and CBER have indicated support for v1.0 and v2.0 of Define-XML in the FDA Data Standards Catalog. The FDA has also announced the end of support for Define-XML v1.0 for studies that start 12 months after 15 March 2017.
Define-XML v2.0 represents a significant update to Define-XML v1.0 in response to implementation experience with v1.0, the evolution of the SDTM, SEND and ADaM standards and best practices by SDTM and ADaM metadata experts. Key enhancements include:
- Support for CDISC Controlled Terminology
- Flexible definition of Value Level Metadata
- Enhanced documentation of data origin or source
- Improved support for ADaM metadata
- Improved handling of comments.
Define-XML v2.0 is the most current version of this standard and its use is recommended.