Manage clinical trial e-consent and compliance with Claude AI and Google Sheets

Description

This workflow automates end-to-end e-consent management for clinical trials. It captures, validates, timestamps, and stores consent submissions with a full regulatory-compliant audit trail, notifies investigators and participants, and runs daily compliance checks for missing or expiring consents. How it works Capture E-Consent - Webhook receives signed consent submission from participant portal Validate & Timestamp - Verifies all required fields, applies cryptographic timestamp for legal validity Claude AI Compliance Check - Reviews consent form completeness against ICH E6 GCP guidelines Store with Audit Trail - Writes immutable record to Google Sheets with full chain of custody Notify PI & Participant - Sends confirmation emails to principal investigator and participant Daily Expiry Sweep - Scheduled job checks for expiring or missing consents Generate Compliance Report - Produces daily audit summary for regulatory submission Setup Steps Import workflow into n8n Configure credentials: Anthropic API - Claude AI for compliance review Google Sheets - Consent records and audit log SMTP / Gmail - Email notifications to PI and participants DocuSign API (optional) - For e-signature verification Set your trial ID, IRB number, and PI email in the Build Consent Record node Update expiry thresholds in the Daily Expiry Sweep node Activate both the webhook and scheduled workflows Sample Consent Payload { "trialId": "TRIAL-2025-001", "participantId": "P-10042", "participantEmail": "participant@email.com", "participantName": "Jane Doe", "consentFormVersion": "v3.2", "consentDate": "2025-02-22T10:00:00Z", "signatureData": "base64_signature_string", "witnessName": "Dr. Smith", "capacityConfirmed": true, "rightToWithdrawExplained": true, "risksExplained": true, "questionsAnswered": true } Features ICH E6 GCP compliant** validation with Claude AI review Immutable audit trail** with hash-based record integrity Automated expiry alerts** for re-consent workflows Daily compliance report** ready for IRB/regulatory submission Full chain of custody** — who captured, reviewed, and stored every record Explore More LinkedIn & Social Automation: Contact us to design AI-powered lead nurturing, content engagement, and multi-platform reply workflows tailored to your growth strategy. An n8n automation workflow template by Oneclick AI Squad.

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• 6 nodes
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