eConsent Step-by-Step Guide

e-Consent Step-by-Step

This guide walks through the setup and configuration of REDCap’s e-Consent Framework and PDF Snapshot functionality. These tools allow study teams to present consent forms electronically, capture participant signatures, and automatically generate archived PDF copies of completed consent documentation.

Before You Begin:

  • Discuss the proposed e-Consent workflow with your IRB before implementation.
  • Ensure the consent language and process have appropriate IRB approval.
  • Determine whether the study requires 21 CFR Part 11 compliance.
  • Build and test the full workflow in Development before moving to Production.

Step 1: Enable Surveys in the Project

The e-Consent Framework can only be used with REDCap survey instruments.

  1. Navigate to Project Setup.
  2. Under Main Project Settings, enable:
    • Use surveys in this project?
Tip: If the project was originally built only for data entry, enabling surveys converts instruments into participant-facing forms.

Step 2: Build the Consent Instrument

  1. Go to the Online Designer.
  2. Create a new instrument or modify an existing one.
  3. Add all required consent content and fields.

Recommended Fields

  • Participant first name
  • Participant last name
  • Date of birth (optional, depending on workflow)
  • Signature field
  • Date signed
  • Required acknowledgements/check boxes
Important: Signature fields used for e-Consent should be marked as Required Fields.

Consent Display Options

REDCap supports two primary approaches:

  • Inline PDF Consent (Recommended):
    Upload the IRB-approved consent PDF so participants view the exact approved document.
  • Rich Text Consent:
    Build the consent language directly inside REDCap using descriptive text fields and formatting.
Best Practice: Use the Inline PDF option whenever possible for regulated or formally approved research studies.

Step 3: Enable the Instrument as a Survey

  1. Return to the Online Designer.
  2. Locate the consent instrument.
  3. Select Enable under the survey column.
  4. Configure any desired survey settings.

Common Survey Settings

  • Survey title
  • Instructions
  • Save & Return Later
  • Survey Queue
  • Automated Survey Invitations (ASIs)
  • Survey Notifications

Step 4: Open the e-Consent Framework

  1. From the Online Designer, select:
    • e-Consent and PDF Snapshots
  2. Select:
    • Enable the e-Consent Framework for a survey
  3. Choose the survey instrument you want to use for consent.

Step 5: Configure e-Consent Settings

REDCap will prompt you to configure the e-Consent settings.

Required Configuration

  • First Name field
  • Last Name field
  • Signature field
  • Date

Optional Configuration

  • Date of birth field
  • Custom PDF header
  • Custom PDF footer
  • File naming format
  • Additional PDF storage location
Note: REDCap automatically saves completed e-Consent PDFs to the File Repository. This automatic archive cannot be disabled.

Step 6: Add the Consent Form Version

  1. Select Add consent form.
  2. Enter the consent version number.
  3. Select the descriptive field where the consent should display.
  4. Upload the approved consent PDF or add consent text.
  5. Save the consent version.

Versioning Considerations

  • Each REDCap consent version must be unique.
  • Version numbers cannot be reused once activated.
  • Maintain consistency between IRB approval versions and REDCap versions.
Important: Once saved, the new consent version becomes active immediately.

Step 7: Configure PDF Snapshot Settings (Optional Advanced Setup)

Additional PDF Snapshot triggers can be configured to generate custom PDFs or combine multiple forms into a single document.

  1. Navigate to:
    • e-Consent and PDF Snapshots
    • PDF Snapshots of Records
  2. Select Add new trigger.

Example Trigger Logic

[consent_complete] = “2”

Additional Options

  • Select which instruments to include
  • Save a single survey or combine multiple surveys
  • Store translated versions (MLM)
  • Save to File Repository or File Upload fields
  • Customize PDF file names using piping

Step 8: Multi-Signature or Multi-Form Workflows

Some studies require multiple signatures, such as:

  • Participant + research staff
  • Parent/guardian + child assent
  • Legally authorized representative workflows

In these situations:

  • Create separate instruments for each signing role when appropriate.
  • Enable e-Consent independently for each survey.
  • Use PDF Snapshot triggers to combine completed forms into a single PDF if desired.

Example Multi-Signature Logic

[participant_sign_complete]=”2″ AND [staff_sign_complete]=”2″

Step 9: Multi-Language Management (MLM)

REDCap’s Multi-Language Management module can be used with e-Consent workflows.

Recommended MLM Workflow

  • Enable MLM in Project Setup
  • Create translated consent content
  • Add separate consent versions for each language
  • Test all translated PDFs carefully

Step 10: Data Access Groups (DAGs)

DAGs can be used to support site-specific or role-specific consent workflows.

  • Create DAGs on the User Rights page
  • Assign users appropriately
  • Configure DAG-specific consent versions if needed
  • Verify that access restrictions work correctly

Step 11: Test the Entire Workflow

Thorough testing is critical before moving an e-Consent project to Production.

Recommended Testing Checklist

  • Test on desktop and mobile devices
  • Verify required fields and signatures
  • Confirm survey certification works correctly
  • Verify PDF generation and storage
  • Review the generated PDF carefully
  • Test Survey Queue and ASI behavior
  • Test MLM and DAG workflows if used
  • Verify all branching logic and calculations

Additional Guidance

  • REDCap automatically maintains audit trails for e-Consent and PDF Snapshot activity.
  • REDCap data is encrypted during transmission, but storage encryption depends on institutional infrastructure and configuration.
  • Always validate the final generated PDF output before using e-Consent in a live study.

For assistance with REDCap e-Consent setup or workflow design, please contact the REDCap Administrator before moving your project to Production.