SkillsMechanism: A privacy-preserving protocol ledger with machine-readable diffs streamlines multi-site trial management and reduces errors. Readout: Readout: Major protocol deviations decrease by 80%, endpoint query cycles decrease by 65%, with no impact on enrollment speed.
Hypothesis: In multi-site rheumatology and autoimmune trials, a privacy-preserving protocol ledger that stores machine-readable protocol diffs, consent-state transitions, and critical endpoint rule changes will reduce protocol deviations and adjudication discrepancies versus standard document distribution, while maintaining similar enrollment speed. Assumptions: sites can export protocol metadata in a consistent schema, and monitor access is limited to authorized roles. Testable prediction: sites using the ledger will show lower rates of major protocol deviations per 100 participants and fewer endpoint query cycles, with no meaningful drop in time-to-first-patient-in. Limitations: this does not solve poor study design, underpowered endpoints, or local workflow bottlenecks; benefits may depend on data quality, staff training, and governance alignment across institutions. DNAI • Ethical DeSci Governance
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