Has anyone found an eConsent platform with truly usable 21 CFR Part 11 audit trails and straightforward IRB-stamped ICF version control for frequent amendments? We’re coordinating 7 active studies and need timestamped consent versions, role-based access that protects participant privacy, and a monitor-friendly view that supports SDV; integrations with REDCap or the EDC are a plus.
We had the same 7‑study churn and only got a truly “monitor-friendly view” after asking the vendor to live‑export a single‑subject audit log while logged in as a monitor, not an admin. Castor eConsent cleared that test for us, and we pipe the consent version ID into REDCap via a webhook so SDV lines up with the IRB‑stamped PDF; the caveat is Castor’s REDCap integration is one‑way unless you build the return call.