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


Excel Report

The new Excel Report is very fluid and easier to read however there is one thing that was taken away and I was wondering if I could put it back in easily. Before the Issue Summary tab just had total counts of all known issues; even though going into the Details tab to find out which domains these belong was tedious it at least gave you an overview and possible a big picture type view. You could see if there were consistent issues happening in multiple domains.  Right now we could easily subset the Issue Summary tab however the Domain isn't on every line.  I see 2 options that would help me:

  • First (and probably the easier one) just place the Domain on every line. Then sub setting on Message you can easily see all the domains with that issue.
  • Or second change the format so the Source column would be a comma (or tab) separate list of all the domains this specific issue was in (almost like the new version and the old version combined).

Is this possible to do by updating any of the configuration files?  Thank you for any information or help you can provide.

~ Victor Falch

At this point lay-outs of OpenCDISC

Hi Victor,

At this point lay-outs of OpenCDISC validation reports are not easy configurable. They are a part of the validator programming code.

You can contact Pinnacle21 for service or consider Enterprise version.