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

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

1. Capture E-Consent - Webhook receives signed consent submission from participant portal
2. Validate & Timestamp - Verifies all required fields, applies cryptographic timestamp for legal validity
3. Claude AI Compliance Check - Reviews consent form completeness against ICH E6 GCP guidelines
4. Store with Audit Trail - Writes immutable record to Google Sheets with full chain of custody
5. Notify PI & Participant - Sends confirmation emails to principal investigator and participant
6. Daily Expiry Sweep - Scheduled job checks for expiring or missing consents
7. Generate Compliance Report - Produces daily audit summary for regulatory submission

Setup Steps

1. Import workflow into n8n
2. 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
3. Set your trial ID, IRB number, and PI email in the Build Consent Record node
4. Update expiry thresholds in the Daily Expiry Sweep node
5. Activate both the webhook and scheduled workflows

Sample Consent Payload

{
  "trialId": "TRIAL-2025-001",
  "participantId": "P-10042",
  "participantEmail": "[email protected]",
  "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

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