Define-XML transmits metadata that describes any tabular dataset structure. When used with the CDISC content standards, it provides the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM.
Define-XML is required by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used.
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.
Version 2.1 of Define-XML includes all of the material from the Define-XML v2.0 specification in addition to Define-XML v2.1 changes, which include an updated approach to def:Origin, identification of the standards and controlled terminology versions referenced in a Define-XML document, added support for sub classes, improved SENDIG support, v2.0 errata fixes, and additional updates.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.
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:
Define-XML v2.0 is the most current version of this standard and its use is recommended.
ARM v1.0 for Define-XML v2 supports the submission of ARM as defined in ADaM v2.1. The release package consists of a zip file that includes a readme file, the specification document, an ADaM-based Define-XML example and the ARM schema. Please refer to the readme file for further details.
|ARM v1.0 for Define-XML v2||1.36 MB|
|ARM v1.0 for Define-XML v2.0 Public Review Comments||32.33 KB|
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.