Tag: SAS XML Mapper

Face Off: Review OpenCDISC XML files

OpenCDISC, the first open source CDISC validator, is already in the toolbox of FDA reviewers (CDER/CBER, see CDISC Standards in the Regulatory Submission Process, 26 January 2012, P.33). The key features in OpenCDISC is a dichotomy of validation rules (XML based) and application logic. Currently OpenCDISC Validator (Version 1.2.1) officially supports the four following CDISC […]