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.
Stat Programming
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.
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.
CONSORT, SPIRIT, and ICMJE All Update at Once — Your Templates Can't Keep Up
Three foundational reporting standards refreshed inside a year, and none of them harmonises with ICH E3. The confluence is the problem — not any single checklist change.
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.
CONSORT 2025's New Statistical Items Land in Statisticians' Laps
Four reporting standards updated in thirteen months — the operational squeeze falls hardest on the SAP, the missing-data section, and the TLF shell your team built to CONSORT 2010.
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.