ConsentLedger

ConsentLedger is a web app (with optional mobile-friendly participant view) that helps research teams manage informed consent versions, re-consent events, and audit-ready records across multi-site studies. It centralizes consent templates, tracks which participant signed which version, and flags when protocol amendments require re-consent. Instead of pretending to replace IRBs, it focuses on the messy operational layer: documenting consent conversations, capturing participant questions, and producing a clean export for monitors and auditors. It supports eConsent links, but also accommodates paper workflows via scan upload and structured metadata. An AI assistant can summarize consent-call notes into standardized fields and detect missing required elements (e.g., risks, withdrawal language) based on your institution’s checklist—without making approval decisions. The goal is fewer compliance surprises, faster monitoring visits, and less staff time spent reconstructing consent history.