PMDA's New Validation Rules Explained

December 18, 2019

On Friday, September 27th, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) published its long-awaited update to validation rules for SDTM, ADAM and Define.xml. PMDA Validation Rules 2.0 introduce additional standard conformance rules from CDISC, support for analysis result metadata (ARM), and many other changes. At Pinnacle 21, we've got you covered. We have released support for these new rules in our latest validation engine.

Pinnacle 21 recently hosted a webinar discussing the PMDA's new validation rules for clinical data. You can watch the video, access the slides and review the Q&A list. For your convenience, we also offered this webinar in a brand new Japanese language session with the video and the slides available for viewing.