On November 24th, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) published its first official list of validation rules for CDISC SDTM, ADaM and Define.xml. These long awaited rules cover conformance, reviewability and quality requirements, as described in the PMDA Technical Conformance Guide on Electronic Study Data Submissions. The rules will ensure that data conform to the standards and support ease of use and meaningful analysis.
The PMDA agency is asking sponsors to validate their study data before submission — using these published validation rules — and either correct any validation issues or explain why they could not be corrected in the data guide. PMDA has introduced new “Reject” rules, which, if violated, will cause the review to be suspended until issues are corrected. PMDA can also suspend review if explanations for certain issues are not provided.
Rest assured, these rules have now been implemented in Pinnacle 21 Enterprise and Pinnacle 21 Community 2.1 — keeping you ahead of the curve. Join Max Kanevsky — founder of OpenCDISC and Pinnacle 21 — in our webinar to learn about the new PMDA validation rules, how they differ from rules published by FDA, and what you can do to get compliant in time for your next submission.