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

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.

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.

Hi everyone, The OpenCDISC Validator's initial release is finally ready! Download OpenCDISC Validator Alpha now! The OpenCDISC Validator Alpha handles approximately 70% of documented validation rules, which are included in 3 flavors: Janus v0.1, WebSDM v2.6, and a hybrid of the two. We are looking forward to your feedback. We are especially interested in the following:

OpenCDISC and the Validator were presented at CDISC Interchange on Wednesday. The session was very well received by all who attended. We'd like to thank everyone for all the great feedback and support. In case you missed it, you can download slides from the presentation here (PDF).