Standards & Readiness Watch
Work through a curated, manually-reviewed reading list of authoritative source families, record your review locally, and send a relevant signal into Readiness Intelligence before it becomes a late implementation problem. This is a reading and tracking aid, not an automated feed — nothing here is monitored unless you open this page and check it yourself.
Authoritative source monitor
The watchlist does not reinterpret requirements. It makes the monitoring and internal-decision step visible.
The FDA page identifies the technical specifications document as current thinking and shows a June 12, 2026 update. Check whether revised recommendations affect dataset, metadata, reviewer-guide, validation, or package decisions.
Use the catalog and study-data resource hub to confirm which standards and versions are supported, required, or planned for the relevant submission context.
CDISC Controlled Terminology supplies codelists and values used with CDISC-defined data items. Review releases against sponsor-controlled terminology and the versions applicable to each study.
Annex 2 reached Step 4 in June 2026 and addresses GCP considerations for decentralized and pragmatic elements and real-world data. Assess operational relevance with Clinical, Data Management, Statistics, Safety, and governance functions.
Monitor FDA notices and implementation material for eCTD requirements and v4.0 transition planning. Confirm regional and application-specific expectations before changing publishing or package workflows.