Define-XML is a standardized format used to describe the structure and content of datasets submitted to regulatory agencies. It ensures that metadata such as variable names, types, labels, derivations, and controlled terminology are clearly documented and accessible for reviewers.
Define-XML is required by regulatory authorities like the FDA (U.S.) and PMDA (Japan) as part of all electronic study submissions. It enables these agencies to efficiently interpret and validate clinical data.
Define-XML supports metadata documentation for datasets following SDTM (for tabulation data), ADaM (for analysis datasets), and SEND (for nonclinical/animal studies).
Yes. We specialize in converting and mapping legacy clinical data into CDISC-compliant formats, including the creation of corresponding Define-XML files for historical studies.
Yes, Define-XML has different versions (e.g., 1.0, 2.0). TechyVignan ensures your submission aligns with the latest regulatory requirements, typically Define-XML v2.0, which is widely accepted by the FDA and PMDA.
