Blog

OpenCDISC Validator Goes Beta!

July 27, 2009
Hi everyone, We are happy to announce the release of OpenCDISC Validator Beta. This is a major milestone bringing us another step closer to production. Download OpenCDISC Validator Beta here

What's New in Beta

  • Support for 100% of documented Janus and WebSDM validation rules
  • 10 additional rules contributed by the community
  • Validation checks against define.xml
  • Validation checks against CDISC Terminology
  • New report formats including Excel and CSV, in addition to HTML

OpenCDISC Validator Alpha 2 Released

February 16, 2009
Hi everyone, The Alpha 2 release of the OpenCDISC Validator is now available! Download OpenCDISC Validator Alpha 2 here The latest version introduces a number of new features with most important being the capability to perform cross-dataset validations and lookup validations. The latter allows dataset content to be validated against dictionaries such as MedDRA and LOINC as well as data management and trial management systems. This is made possible by the ability to define rules against data stored in a number of supported database engines and external SAS® XPORT files. Currently supported databases are Oracle, SQL Server, and MySQL.

Janus Compliance with OpenCDISC Validator

November 12, 2008
So your company has decided to submit SDTM datasets to FDA. You have worked tediously to make sure that your datasets comply with SDTM Implementation Guide (SDTMIG). You even validated your datasets with WebSDM. Can you be sure that your data will successfully load into FDA's Janus data warehouse? The short answer is No, as has been demonstrated by the Sanofi-Aventis team in their paper Experiences Submitting CDISC SDTM and Janus Compliant Datasets.