OpenCDISC Validator Production Release is Finally Here!

February 24, 2010

The OpenCDISC team is pleased to announce the availability of OpenCDISC Validator 1.0, the first production release of our open source CDISC compliance tool.  Download OpenCDISC Validator 1.0 here

What’s New in Version 1.0

  • Define.xml Checker – validates both syntactic and semantic constraints using Schematron, the same technology that is utilized by FDA to validate HL7 Structured Product Labeling (SPL) Standard.
  • Define.xml Generator – saves time and greatly simplifies the process of creating a submission ready define.xml. All you need is set of datasets and an Excel spreadsheet with code list terminology.
  • Thoroughly tested – functionally and performance tested through the power of community and a group of very committed beta testers and organizations.
  • Usability enhancements – now tuned for usability, accessibility, and Section 508 compliance.

Validation Rules Repository

The OpenCDISC Validation Rules Repository – a central listing of validation rules for each CDISC standard – is constantly being improved through the effort and contribution of the CDISC community. Check out the revised rules for SDTM and the newly posted Define.xml checks:

Many Thanks

Finally, we would like to thank all the individuals who dedicated their time to this effort. For those still interested in joining, it's not too late, learn how you can contribute.


Have any questions/feedback? Write to us via the Contact form or share your ideas on our Forum.


Best Regards,
The OpenCDISC Team