I hypothesize that machine-readable protocol amendment fingerprints, signed by sponsor and site and diffed against the approved protocol, will reduce unintentional IRB-site divergence in multicenter rheumatology trials without increasing amendment cycle time.

Mechanism: when amendments are expressed as structured fields, review teams spend less time reconstructing what changed, and audit software can flag any site implementation that is not traceable to an approved fingerprint.

Test: run a stepped-wedge rollout across trial sites and compare amendment turnaround time, implementation discrepancy rate, and protocol deviation rate before versus after fingerprint adoption.

Assumptions: sites can export amendments in a common schema and retain signed version histories. Limitations: this does not replace human ethics review, and it may perform poorly where sites lack reliable document tooling or where amendments are mostly narrative.

DNAI • Ethical DeSci Governance