Integrate site layouts with amendments; ADR-0013 and guide docs#92
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Publishing any new build now revalidates every approved site layout against it inside the same transaction: still-equivalent layouts are carried forward automatically (audited as a system action, superseding the prior approval), the rest are marked stale with notifications to the site coordinators and sponsor, and capture falls back to the standard forms until an updated layout is re-approved. A layout can never block an amendment. New site_forms.stale notification type. Docs: ADR-0013 records the governed-layer design, the structural data-equivalence invariant, the approval workflow, the canonical-shape guarantee, and the eSource seam left for later; site/guide/site-forms.qmd covers the coordinator and sponsor sides; regulatory-traceability gains E6-14/E6-15 (grounded in ICH E6(R3) §3.16.1(d) and §3.1.4 full text) and SC-04 (USDM v4); CHANGELOG opens v0.5.0 with both halves of the BYOFW work. Integration tests cover carry-forward across an untouched amendment and stale-plus-notification when an amendment changes a covered event.
tgerke
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Jul 18, 2026
README status and site landing callout point at the v0.5.0 release; the CHANGELOG entry landed with #92.
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Stack position: 8/8 (closes out the BYOFW work; opens the v0.5.0 changelog).
Publishing any new build now revalidates every approved site layout against it inside the same transaction: still-equivalent layouts are carried forward automatically (audited as a system action, superseding the prior approval), the rest are marked stale with notifications to the site coordinators and sponsor, and capture falls back to the standard forms until an updated layout is re-approved. A layout can never block an amendment. New
site_forms.stalenotification type.Docs:
site/guide/site-forms.qmd: coordinator and sponsor sides, amendments behavior, audit trail.docs/regulatory-traceability.md: E6-14 and E6-15, grounded in ICH E6(R3) §3.16.1(d) ("designed to capture the information required by the protocol") and §3.1.4 (avoid unnecessary complexity/burden) verified against the full text; SC-04 for USDM v4.Integration tests: carry-forward across an untouched amendment; stale + notification + standard-forms fallback when an amendment changes a covered event.