eConsent

Versioned consent with Part 11 signatures and automatic re-consent.

Consent documents are versioned study artifacts. When an amendment changes consent-relevant content, every affected subject is flagged for re-consent at their next visit, automatically.

Signing that holds up to inspection

Signatures meet 21 CFR Part 11: identity verification, re-authentication at signing, and a signature manifest binding signer, time, and meaning to the exact document version signed.

Part 11 signature and countersignature flows
Subject copy delivery
Remote consent with telehealth hook
Identity verification recorded with the consent event

HIPAA authorization as data

The HIPAA authorization is tracked per subject with capture, version, and revocation. Revoking it gates downstream sponsor visibility the moment it happens.

Per-subject authorization lifecycle
Revocation gates downstream data sharing
Consent version coverage visible on the compliance dashboard

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