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

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1. Workflow Overview

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, notifie...

Best for

Document Extraction automation workflows
AI Summarization automation workflows
advanced n8n builders looking for reusable templates

Tools used

n8n-nodes-base.stickynote, n8n-nodes-base.webhook, n8n-nodes-base.code, n8n-nodes-base.httprequest, n8n-nodes-base.googlesheets, n8n-nodes-base.if, @n8n/n8n-nodes-langchain.agent, @n8n/n8n-nodes-langchain.lmchatanthropic

Source and attribution

This workflow is cataloged by N8N Workflows and links back to its original n8n.io source page by Oneclick AI Squad.

Original n8n.io source

1.1 Workflow description

Title: Manage clinical trial e-consent and compliance with Claude AI and Google Sheets
Workflow name: 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

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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1.2 Logical Blocks

This catalog entry is organized from the workflow JSON. The node-level section below shows the executable blocks available for review before importing the template.

2. Block-by-Block Analysis

Block 1 - Sticky Note

Type / Role: n8n-nodes-base.stickyNote - stickyNote
Config choices: Version 1

Block 2 - Sticky Note1

Type / Role: n8n-nodes-base.stickyNote - stickyNote
Config choices: Version 1

Block 3 - Sticky Note2

Type / Role: n8n-nodes-base.stickyNote - stickyNote
Config choices: Version 1

Block 4 - Sticky Note3

Type / Role: n8n-nodes-base.stickyNote - stickyNote
Config choices: Version 1

Block 5 - Sticky Note4

Type / Role: n8n-nodes-base.stickyNote - stickyNote
Config choices: Version 1

Block 6 - Receive E-Consent Submission

Type / Role: n8n-nodes-base.webhook - webhook
Config choices: Version 2

Block 7 - Validate and Timestamp Consent

Type / Role: n8n-nodes-base.code - code
Config choices: Version 2

Block 8 - Verify E-Signature via DocuSign

Type / Role: n8n-nodes-base.httpRequest - httpRequest
Config choices: Version 4.2

Block 9 - Check for Duplicate Consent Record

Type / Role: n8n-nodes-base.googleSheets - googleSheets
Config choices: Version 4.5

Block 10 - Flag Duplicate or Proceed

Type / Role: n8n-nodes-base.if - if
Config choices: Version 2

Block 11 - Claude AI GCP Compliance Review

Type / Role: @n8n/n8n-nodes-langchain.agent - agent
Config choices: Version 1.6

Block 12 - Claude AI Model

Type / Role: @n8n/n8n-nodes-langchain.lmChatAnthropic - lmChatAnthropic
Config choices: Version 1

Block 13 - Parse Compliance Review

Type / Role: n8n-nodes-base.code - code
Config choices: Version 2

Block 14 - Store Consent Record with Audit Trail

Type / Role: n8n-nodes-base.googleSheets - googleSheets
Config choices: Version 4.5

Block 15 - Notify Principal Investigator

Type / Role: n8n-nodes-base.emailSend - emailSend
Config choices: Version 2.1

Block 16 - Send Confirmation to Participant

Type / Role: n8n-nodes-base.emailSend - emailSend
Config choices: Version 2.1

Block 17 - Build Consent Response

Type / Role: n8n-nodes-base.code - code
Config choices: Version 2

Block 18 - Send Consent Confirmation Response

Type / Role: n8n-nodes-base.respondToWebhook - respondToWebhook
Config choices: Version 1

Block 19 - Daily Compliance Sweep Trigger

Type / Role: n8n-nodes-base.scheduleTrigger - scheduleTrigger
Config choices: Version 1.2

Block 20 - Fetch All Active Consent Records

Type / Role: n8n-nodes-base.googleSheets - googleSheets
Config choices: Version 4.5

Block 21 - Analyse Expiring and Missing Consents

Type / Role: n8n-nodes-base.code - code
Config choices: Version 2

Block 22 - Send Daily Compliance Report to PI

Type / Role: n8n-nodes-base.emailSend - emailSend
Config choices: Version 2.1

Block 23 - Log Sweep Results to Audit Sheet

Type / Role: n8n-nodes-base.googleSheets - googleSheets
Config choices: Version 4.5

Block 24 - Wait For Load

Type / Role: n8n-nodes-base.wait - wait
Config choices: Version 1.1

3. Summary Table

Workflow	Manage clinical trial e-consent and compliance with Claude AI and Google Sheets
Complexity	advanced
Nodes	24
Categories	Document Extraction, AI Summarization
Author	Oneclick AI Squad
Published	04 Nov 2025

4. Reproducing the Workflow from Scratch

1. Download the workflow JSON

Use the JSON export at /data/workflows/10492/10492.json as the source template for this automation.
2. Import the template into n8n

Open n8n, import the downloaded JSON, and review each node before activating the workflow.
3. Configure credentials and variables

Replace placeholder credentials, API keys, webhook URLs, account IDs, and environment-specific values with your own settings.
4. Test with sample data

Run the workflow manually or in a staging workspace, inspect node output, and confirm downstream systems receive the expected data.
5. Activate and monitor

Enable the workflow only after testing, then monitor executions, errors, and rate limits during the first production runs.

5. General Notes & Resources

Review imported nodes carefully before activation. This catalog entry is intended to help you inspect the workflow structure, understand required services, and find related templates faster.

Node names, credentials, schedules, webhook paths, and external service limits may need adjustment for your workspace.

Download workflow JSON Original n8n.io source Document Extraction workflows AI Summarization workflows

Frequently asked questions

What does Manage clinical trial e-consent and compliance with Claude AI and Google Sheets do?

What do I need before importing this workflow?

Review the workflow JSON, configure any required credentials in n8n, and test the automation in a safe workspace before using it in production.

Can I customize this workflow?

Yes. Use the block-by-block analysis and the downloadable JSON to inspect each node, then adjust credentials, prompts, schedules, filters, or destinations for your Document Extraction, AI Summarization use case.

Oneclick AI Squad

224 workflows

Nodes

n8n-nodes-base.stickynote n8n-nodes-base.webhook n8n-nodes-base.code n8n-nodes-base.httprequest n8n-nodes-base.googlesheets n8n-nodes-base.if @n8n/n8n-nodes-langchain.agent @n8n/n8n-nodes-langchain.lmchatanthropic

Complexity

advanced

Published 04 Nov 2025

Likes 0

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Install path: /data/workflows/10492/10492.json

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

Workflow preview

1. Workflow Overview

Best for

Tools used

Source and attribution

1.1 Workflow description

How it works

Setup Steps

Sample Consent Payload

Features

1.2 Logical Blocks

2. Block-by-Block Analysis

Block 1 - Sticky Note

Block 2 - Sticky Note1

Block 3 - Sticky Note2

Block 4 - Sticky Note3

Block 5 - Sticky Note4

Block 6 - Receive E-Consent Submission

Block 7 - Validate and Timestamp Consent

Block 8 - Verify E-Signature via DocuSign

Block 9 - Check for Duplicate Consent Record

Block 10 - Flag Duplicate or Proceed

Block 11 - Claude AI GCP Compliance Review

Block 12 - Claude AI Model

Block 13 - Parse Compliance Review

Block 14 - Store Consent Record with Audit Trail

Block 15 - Notify Principal Investigator

Block 16 - Send Confirmation to Participant

Block 17 - Build Consent Response

Block 18 - Send Consent Confirmation Response

Block 19 - Daily Compliance Sweep Trigger

Block 20 - Fetch All Active Consent Records

Block 21 - Analyse Expiring and Missing Consents

Block 22 - Send Daily Compliance Report to PI

Block 23 - Log Sweep Results to Audit Sheet

Block 24 - Wait For Load

3. Summary Table

4. Reproducing the Workflow from Scratch

1. Download the workflow JSON

2. Import the template into n8n

3. Configure credentials and variables

4. Test with sample data

5. Activate and monitor

5. General Notes & Resources

Frequently asked questions