Sampled — shipped under file-level sampling, not individually fact-checkedcommunity attestations: 0✓ / 0✗
Steps
Authenticate to the Florence Healthcare API using the API key provided in the Florence admin portal, included as a Bearer token in the Authorization header
List consent records for a study via the API endpoint for consent submissions, filtering by site ID and study ID to scope results to the relevant trial
Retrieve each consent record's metadata including participant identifier, consent form version, signed timestamp, consenting staff name, and authentication method used
Download the signed consent PDF for each record and verify the document integrity using the digital signature embedded in the PDF (Florence eBinders produces Part 11-compliant signed PDFs)
Export the audit log for each consent event from Florence to demonstrate the chain of custody: who initiated the consent, what was presented to the participant, and when the participant signed
Cross-reference consent form version numbers against IRB-approved amendment dates stored in the eTMF to confirm the correct version was used for each enrollment date
Known gotchas
Florence eConsent is validated as a system under 21 CFR Part 11 but the sponsor remains responsible for system validation documentation (IQ/OQ/PQ) and must obtain Florence's vendor qualification package
Consent records must be retained per the study protocol and applicable regulation; Florence data exports must be archived in a sponsor-controlled system before study closeout to avoid dependency on the vendor's retention policy
Paper fallback consent forms executed outside Florence must be uploaded and linked to the participant record manually; automated reconciliation cannot detect orphaned paper consents
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