ADR-0016: RTSM is a separate application, not an edc-core module - #114
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RTSM functionality (randomization, supply) will be built as a sibling application with its own repo and database, integrating through the ADR-0010 intake like any commercial RTSM. Rationale: structural blinding boundary (Annex 1 §4.1), dogfooding the integration seam, and keeping randomization's validation burden (Annex 1 §4.3.4(h)) out of edc-core's validation envelope. Regulatory wording verified against the E6(R3) source mirror.
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What
Records the decision that RTSM functionality (randomization and trial supply management) will be built as a sibling application — working name rtsm-core — rather than grown inside edc-core. Docs-only: one new file,
docs/adr/0016-rtsm-separate-application.md. ADR-0010 stays accepted; this answers the question its scope note left open.Why separate
Rejected alternatives recorded in the ADR: in-EDC randomization module (REDCap/OpenClinica pattern), separate service on a shared database, second app in this repo.
Source grounding
All E6(R3) references (glossary DAT definition, Annex 1 §4.1.1–4.1.2, §4.3.4(h)) verified verbatim against
~/claude-clinical-skills/sources/ICH/ich-e6-r3.txt. The characterization of commercial sponsor practice (deliberately splitting RTSM/EDC vendors) is industry observation, not a citation — flagged here per house rule.Verification
Docs-only;
biome check docsconfirms the path is outside lint scope. No code, site, or traceability-matrix changes.