OpenCDISC Validator 1.3 Released

The OpenCDISC team is pleased to announce the availability of OpenCDISC Validator 1.3.
Download OpenCDISC Validator 1.3 here

What's New in Version 1.3

The latest release introduces a number of major enhancements and usability improvements. The validation engine has been upgraded to support split datasets. The Excel report has been revised to improve readability. For example the issues summary tab is now grouped by domain, while terminology issues are collapsed into instances of distinct terms thus significantly reducing the size of the details tab. Also, the process of enabling MedDRA validation has been simplified. Please refer to Configuring OpenCDISC Validator for MedDRA guide for more information.

For a complete listing of enhancements and bug fixes please refer to the changelog.

SEND, SDTM Amendment 1, and other Validation Rule Updates

We are also happy to announce support for SEND 3.0 and SDTM 3.1.2 Amendment 1 standards. Now is your chance to test drive your data against these checks. Please post your questions/comments on the forum. We are looking forward to your feedback.

In addition, we have released updates to validation rules for SDTM 3.1.2, SDTM 3.1.1, ADaM 1.0, and Define.xml 1.0 standards. The most notable enhancements are:

  • Added 43 new SDTM validation rules
  • Revised most SDTM rule messages and descriptions for consistency
  • Updated ADAM rules to align to the v1.1 release of validation checks from CDISC ADaM team
  • Added a check for valid MedDRA version in Define.xml

For a complete list of validation rule changes please refer to the release notes or review the latest rules posted on OpenCDISC Validation Rules Repository.

Finally, we would like to thank the community for the continuing support and encouragement. Write to us via the Contact form or share your ideas on our Forum.

Best Regards,
The OpenCDISC Team