Consent form management and tracking

Purpose

1.1. Automate the distribution, collection, monitoring, and compliance tracking of electronic consent forms for clinical studies and patient programs in pharmaceutical manufacturing.
1.2. Automatically issue forms, remind participants, track completion statuses, log timestamps, and ensure regulatory documentation is maintained for audits.
1.3. Enable automated notifications for missing/incomplete consents, automate integration to trial management/ERP systems, and permit automated reporting for compliance teams.

Trigger Conditions

2.1. New clinical trial participant added to patient database.
2.2. Scheduled trial milestone (e.g., site initiation, protocol update, re-consent needed).
2.3. Periodic consent validity checks via automated scheduler.
2.4. Consent form signed/submitted/change detected in the database.
2.5. Compliance review cycle initiated or deadline approaching.

Platform variants

3.1 DocuSign
• Feature/Setting: Automate Envelope Creation/Send Agreement API to issue and track e-signature requests.
3.2 Adobe Sign
• Feature/Setting: Automated Agreement Send/Reminder APIs to dispatch and monitor consent forms.
3.3 Google Workspace
• Feature/Setting: Google Forms automated creation, Google Sheets integration for status updates using Apps Script triggers.
3.4 Microsoft Power Automate
• Feature/Setting: Automate consent form flows between SharePoint, Outlook, and Teams; trigger on item creation.
3.5 Salesforce Health Cloud
• Feature/Setting: Flows/Process Builder for automated consent request and tracking on patient record updates.
3.6 Medidata Rave
• Feature/Setting: Patient Consent module trigger, automated reporting via Medidata APIs.
3.7 REDCap
• Feature/Setting: Automated Notification/Survey Distribution with API trigger on participant entry.
3.8 Smartsheet
• Feature/Setting: Automated sheet updates and reminders using Smartsheet Workflows and HTTP API.
3.9 AirTable
• Feature/Setting: Automate record tracking and reminders with Airtable Automations and webhook trigger.
3.10 Slack
• Feature/Setting: Automated notification bot/posts on consents due using Incoming Webhooks or Bots API.
3.11 Twilio SMS
• Feature/Setting: Programmatic SMS consent reminders via Twilio Messaging API.
3.12 SendGrid
• Feature/Setting: Automated email outreach for consent requests via SendGrid Email API.
3.13 Zapier
• Feature/Setting: Automated multi-platform workflows connecting clinical data, email, and cloud docs.
3.14 Asana
• Feature/Setting: Automated task creation/assignment on new participants using API or Rules.
3.15 Monday.com
• Feature/Setting: Automated status boards, reminders, and updates using Monday Automations API.
3.16 ServiceNow
• Feature/Setting: Workflow automation for compliance checks with ServiceNow Flow Designer.
3.17 Box
• Feature/Setting: Automated consent form versioning, access control, and upload tracking via Box API.
3.18 Dropbox
• Feature/Setting: Consent form storage automation and reminders for upload confirmation using Dropbox API.
3.19 Trello
• Feature/Setting: Automated card generation for tracking form status, Power-Ups for reminders.
3.20 Qualtrics
• Feature/Setting: Automated consent survey distribution and status retrieval via Qualtrics API.
3.21 Okta
• Feature/Setting: Automated user/participant provisioning and consent authentication using Okta Workflows.

Benefits

4.1. Automates regulatory compliance with auditable logs.
4.2. Automates participant engagement and reduces missed consent scenarios.
4.3. Automated monitoring minimizes staff workload and error rates.
4.4. Enables scalable, automatable, and repeatable consent tracking across trials/sites.
4.5. Ensures automated proactive alerts for renewal and expiration.
4.6. Centralized automated reporting accelerates audits and inspections.