Dataset-JSON, USDM and IDMP arrive in the same quarter
The XPT transport, the document-shaped protocol and the unstructured product dictionary are all being replaced at once — and the migration paths do not line up.
Data Management
FDA says yes to R, no to your Docker image
Pilot 4's review letter, J&J's hybrid pipeline, and a Pinnacle 21 gap together draw the real 2026 boundary between what R submissions can do and what reviewers can actually open.
Data Management Rebrands as Data Science — Mind the Workplan Underneath
A new SCDM chair, a new CCDS credential, a database-lock chapter still in review, and an NIH repository migration all land in the same quarter. The job description is shifting faster than the SOPs.
Three percent of Dryad datasets fail a duplication scan — and that's just the pilot
Three converging items this week reframe source-data trust as the binding constraint on the preclinical, biomarker, and repository data that ultimately feeds regulatory submissions.
CDISC's quiet pivot from files to a data-centric stack
Dataset-JSON now ships with an API standard. The interesting question is whether the metadata underneath is consistent enough for anything to actually query it.
CDISC's Expanding Perimeter Is Outrunning Its Implementation Ecosystem
SDTM was built for interventional trials; FDA is now formalising its use for observational data, while Dataset-JSON v1.1 awaits regulatory acceptance it doesn't yet have.
FDA's R Pilot Review Letters: The Honest Gap Between Proof-of-Concept and Reviewer-Ready
FDA's formal review letters for Pilots 4 and 5 are the first detailed public account of which R submission tooling the agency's IT environment can actually run today.