On February 28th, 2023, PMDA released a new validation rule version 4.0 for SDTM (Study Data Tabulation Model) and Define.XML. A major change in PMDA Validator Rules v4.0 is the support of SDTM IG v3.3, as well as the removal of support of Define.xml 1.0
PointCross Life Sciences has incorporated the updated rulesets on April 28th, 2023. This update enables PointCross users to comply with the latest PMDA requirements for SDTM and Define.XML submissions. In March 2023 PMDA webinar, mentioned there was some consideration of implementation of SDTM IG v3.4 in a future release, however SDTM IG 3.4 is supported by eDV. Also, applicable PMDA define rules were available to execute on SEND datasets. By staying up to date with the latest PMDA validation rules, pharmaceutical and medical device companies can ensure the quality and consistency of their clinical data submissions, leading to faster approvals and improved patient outcomes.
View Supported Validation Rules by PointCross: Clinical and Nonclinical validation Tools
Link to eDataValidator: https://pointcrosslifesciences.com/edatavalidator/