STUDYSAS BLOG

A Define.xml Review Checklist I Actually Use Before Submission StudySAS Blog A Define.xml Review Checklist I Actually Use Before Submission An SDTM-focused practical checklist for reviewing define.xml before submission, with emphasis on reproducibility, traceability, consistency, and the reviewer-facing problems that weak metadata creates. If you work on SDTM submissions long enough, you learn that define.xml is never just a metadata file. It is the reviewer’s map to the datasets, the controlled terminology, the derivations, the value-level rules, and the awkward corners of the study that never fully fit the standard. Over time, I stopped treating validation as the only sign-off gate. I started using a review checklist that asks a harder question: If I were a reviewer opening this package for the first time, would I understand the SDTM data without asking the sponsor what they meant? ...