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: