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": "[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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