Define-XML transmits metadata for SDTM, SEND and ADaM datasets; it is the metadata file sent with every study in each submission, which tells the regulatory authorities what datasets, variables, controlled terms, and other specified metadata were used.
Define-XML is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).
Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.
Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page
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 March 15, 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.
Define.xml v1.0, originally called Case Report Tabulation Data Definition Specification, specifies the standard for providing Case Report Tabulations Data Definitions in an XML format for submission to regulatory authorities. The schema used to define the expected structure for these XML files is based on an extension to the CDISC Operational Data Model (ODM).
XML Schema Validation for Define.xml White Paper
The XML Schema Validation for Define.xml white paper provides guidance on validating Define.xml version 1.0 documents against the Define.xml XML schemas. It proposes practices and tools to improve define.xml schema validation with the goal of fostering consistent validation results to facilitate regulatory submissions and interchange of define.xml documents. The document does not include any define.xml specifications or recommendations for creating define.xml content.
This zip file packages three define.xml version 1.0 examples with copies of the schemas for testing define.xml validation.