Define-XML v2.0 is a major revision of the Define-XML standard for transmission of metadata for SDTM, SEND and ADaM datasets. The model has been extensively refined in response to implementation experience with Version 1.0, evolution of the SDTM, SEND and ADaM standards and best practices by SDTM and ADaM metadata experts.
Key changes 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.
Please read the PDF document ReadMe first. This document provides information about the organization of the release package and other important notes.
Public comment disposition for Define-XML v2.0
Define-XML Referenced in FDA Data Standards Catalog
Beginning with version 3.0 of the FDA Data Standards Catalog, FDA CDER and CBER have indicated support for both v1.0 and v2.0 of Define-XML. Version 1.0 was also previously referenced in the FDA eCTD Study Data Specifications. These documents and others related to FDA submissions are available here.
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. The goal is to foster more 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.
XML Schema Validation for Define.xml (pdf)
This zip file packages three define.xml version 1.0 examples with copies of the schemas for testing define.xml validation.
Define.xml Validation (zip)
Case Report Tabulation Data Definition Specification (CCRT-DDS)
(CRT-DDS, also called define.xml) Version 1.0 (Released for Implementation February 10, 2005)
The CDISC Case Report Tabulation Data Definition Specification (define.xml) Version 1.0 reflects changes from a comment period through the Health Level 7 (HL7) Regulated Clinical Research Information Management Technical Committee (RCRIM) in December 2003 (www.hl7.org) and CDISC's website in September 2004 as well as the work performed by the Define-XML team in conjunction with the CDISC ODM team to add functionality, features, and additional documentation. This document specifies the standard for providing Case Report Tabulations Data Definitions in an XML format for submission to regulatory authorities (e.g., FDA). The XML schema used to define the expected structure for these XML files is based on an extension to the CDISC Operational Data Model (ODM).
The 1999 FDA electronic submission (eSub) guidance and the electronic Common Technical Document (eCTD) documents specify that a document describing the content and structure of the included data should be provided within a submission. This document is known as the Data Definition Document (e.g., "define.pdf" in the 1999 guidance). The Data Definition Document provides a list of the datasets included in the submission, along with a detailed description of the contents of each dataset. To increase the level of automation and improve efficiency of the Regulatory Review process, define.xml can be used to provide the Data Definition Document in a machine-readable format.
Please post any comments, questions or suggestions to CDISC's Public Discussion Forum.
- CRT DDSpecification 1-0-0 (pdf) Case Report Tabulation Definition Specification (define.xml), Version 1.0
- define1-0-0.xsd The define.xml schema version 1.0. This schema 'glues' the extensions and the ODM together to create the full define.xml definition. Applications implementing define.xml should reference only the define1-0-0.xsd directly.
- define-extension.xsd This schema defines where in the ODM the define.xml extensions should appear.
- define-ns.xsd This schema defines where in the ODM the define.xml extensions should appear.
- SchemaFiles.zip A ZIP file that includes all of the schema related files only (define1-0-0.xsd, define-extensions.xsd and define-ns.xsd).
- define1-0-0.xsl An initial define.xml style sheet (Version 1.0).
- Example 1: define.xml An example of the data definition document in XML without a style sheet reference.
- Example 2: define.xml An example of the data definition document in XML with a style sheet reference.
- ExampleFiles.zip A ZIP file that includes both examples, including all referenced external files for the 2nd define.xml example (e.g., define1-0-0.xsl, sample SAS Version 5 Transport Files, blankcrf.pdf and supplementaldatadefinitions.pdf).
- CRT DataDefinitionFiles.zip A ZIP file that contains all of the files referenced above (excluding the above zip files)