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v1.1.0 (2026-10-28)

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@github-actions github-actions released this 28 Oct 05:01
9b9f855

Features

  • feat(study-workspace): study command line for import, info and export (#3125)
  • feat(crf): open plain USDM studies with form items from their concepts (#3122)
  • feat(study-data): report the DEMO-301 win ratio as ARS analyses and Table 14.2.3 (#3121)
  • feat(study-workspace): randomised TAVR versus SAVR reference study for the win ratio (#3120)
  • feat(study-workspace): the TAVR device reference study as USDM (#3118)
  • feat(clinical): standards conformance matrix at /clinical/standards (#3116)
  • feat(study-data): add ADaM for the DEMO-301 hierarchical composite (#3110)
  • feat(crf): bind forms to a visit through one operation in studio and CLI (#3114)
  • feat(standards): add registry fields to the standards bill of materials (#3106)
  • feat(study-workspace): import a USDM study into a workspace without guessing (#3107)
  • feat(study-data): win statistics engine for hierarchical composite endpoints (#3100)
  • feat(clinical-standards): one USDM hand-off envelope for every clinical tool (#3098)
  • feat(standards): standards bill of materials and a weekly standards watch (#3094)
  • feat(deploy): on-demand isolated Preview deployments (ADR 0071) (#3082)
  • feat(crf): carry protocol content in CRF Studio's USDM export (#3069)
  • feat(ops): weekly encrypted backup of the production database (#3048)
  • feat(study-data): show CDISC CORE's recorded findings on the conformance stage (#3058)
  • feat(crf): one form catalog behind one "Add form" surface (#3054)
  • feat(crf): group the studio's modes into Design, Schedule and Verify stages (#3047)

Fixes

  • fix(build): pin the build heap cap and turn off Sentry source maps (#3128)
  • fix(build): turn on webpack memory optimizations for the 8 GB build machine (#3124)
  • fix(ci): fail the CDISC Library sync when the Library read fails (#3113)
  • fix(clinical-standards): never read the first USDM study version silently (#3111)
  • fix(crf): stop the CLI swapping a missing or broken study file for a preset (#3105)
  • fix(study-data): run the CORE workflow on lib/clinical-standards changes (#3103)
  • fix(crf): clear nine CDISC CORE findings on the CRF Studio USDM export (#3061)
  • fix(crf): run CDISC CORE's USDM rules on every CRF Studio export (#3055)
  • fix(cdisc): check every NCI code against the pinned EVS release (#3050)
  • fix(db): let the running site connect as a least-privilege role (#3046)
  • fix(study-data): write the ARS reporting event as valid ARS 1.0 (#3045)
  • fix(crf): make CRF Studio's ODM export valid ODM 1.3.2 and gate it on the XSD (#3039)

Performance

  • perf(nav): prefetch links on hover, focus or touch instead of on scroll (#3089)
  • perf(pwa): precache only the offline shell, not the whole site (#3081)

Other changes

  • docs(readme): show TypeScript 7 in the badge, stack and commands (#3117)
  • build(typescript): type-check with the TypeScript 7 compiler (#3115)
  • ci(study-data): weekly CDISC Library sync of ADaM metadata (#3108)
  • docs(blog): series post 1, one metric, one definition, every tool (#3099)
  • docs(readme): add a banner, screenshots, an arcade gallery and diagrams (#3070)
  • docs(blog): three posts on the release train, schema-checked exports and the AWS warehouse (#3063)
  • refactor(crf): give lib/crf the deep-module shape of lib/study-data (#3060)
  • refactor(clinical-standards): share standards and terminology through one module (#3057)
  • docs(neon): refresh the capacity inventory from the 2026-10-27 audit (#3049)
  • docs(agents): add our own humanizer writing skill (#3042)
  • docs(release): accept ADR 0063 and supersede ADR 0051 (#3040)
  • docs(readme): rewrite the README for v1.0.0 (#3038)
  • docs(blog): Oct 27 post, a conformance engine checks the standard, not the study (#3035)

Commit: 9b9f85514fbdba56b528310023d03d36d95da796

Full changelog: v1.0.0...v1.1.0