Are you Ready for the CDISC Define-XML v2.0 Requirement?

The FDA will end Define-XML v1.0 support for studies that have started after March 15, 2018.  Define-XML is an application used in electronic submissions to facilitate traceability by linking CDISC- based study datasets, metadata including derivations, codelists and computational algorithms, annotated CRFs and reviewer’s guides.  The XML application is rendered within a browser using stylesheets and schema files providing a consistent look and feel for each application across all studies within the NDA or BLA submission.

This new Define-XML v2.0 standard will bring some advantages.  It will include enhancements that make this version more reviewer and programmer friendly as compared to the previous one including:

  • The ability to provide direct links to CDISC Controlled Terminology will also facilitate validation.
  • Value level definitions arranged in slices of data that fall under a specific condition (such as a value of a xxTESTCD) within a domain is a vast improvement in the organization of the value lists.
  • Expanded documentation of the origin for ADaM variable definitions improves the traceability to a predecessor field.
  • Flexible computational methods and comments provide greater functionality and traceability to external definitions or code.

The enhancements implemented within the Define-XML v2.0 application provide for improved study definition within the application and are fueled by standardized metadata.  This facilitates standardized dataset specifications which are the source of the metadata.  Intelligent application and subsequent reuse of these specifications provides the opportunity for developing repeatable programming called macros that automatically create the Define-XML application.   MMS has been utilizing standard macros for years to create the define files for submissions, saving our programmers time and quality   We have updated our suite of specifications and macros and are ready for the new version of Define-XML.  Are you?

Regulatory Submission Support Based on Strong Science and Strength of Process. The difference is in the data!

Contact Us Today!