CS3 — Clinical Trial Records

Setting. A sponsor needs reproducible analysis with privacy constraints.

Design

EPs for data snapshots and analysis notebooks; invariants for numeric results; witness cosign by Data Safety Monitoring Board; restricted category; tombstones for redacted datasets.

Policy Profile

CFS‑Tri; DAVS≥0.75 with replicas across jurisdictions; two-witness rule for protocol amendments.

Workflow

Snapshot raw data → hash and EP → anchor → analysis EP with invariants → publish summary EP with restricted governance.

Evidence & Verification

Verification confirms timing and authorship; invariants flag drift; receipts stitch lineage; tombstones explain withheld files.

Cost & Operations

Tiered anchoring (ETH per milestone; BTC at database lock); controlled replicas with signed retention.

Outcomes

Regulatory audit can be performed offline; reproducibility envelopes capture exact versions.

Risks & Mitigations

Re-identification risk → use redactions with tombstones; ledger FUD → BTC archival; misbinding keys → KBA and witnesses.

KPIs

All milestones anchored; ≥0.9 coverage in segment alignment; no policy violations in restricted replicas.