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

n8nn8n19 modulesv1.0
GmailGoogle SheetsLinkedIn

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 v

At a glance

Manage clinical trial e-consent and compliance with Claude AI and Google Sheets is a ready-made n8n workflow you import as a workflow JSON file — no build required. It connects Gmail, Google Sheets, LinkedIn. It's free to download. Follow the 5-step import below to go live in minutes.

Platform
n8n
Connects
Gmail, Google Sheets, LinkedIn
Modules
19
Price
Free
Version
v1.0
Manage clinical trial e-consent and compliance with Claude AI and Google Sheets workflow diagram

About this workflow

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 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.

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How to import this n8n workflow

  1. 1

    Download the workflow JSON file after purchase.

  2. 2

    Open n8n → click the menu → Import from File.

  3. 3

    Select the downloaded JSON and import.

  4. 4

    Set up credentials for each node that requires them.

  5. 5

    Click Execute Workflow to test, then activate.

Setup guide

Setup guide included

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  • JSON blueprint — instant download
  • Setup guide PDF included
  • 5 downloads · valid 30 days
  • Works with n8n

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