eConsent

e-Consent Framework

REDCap’s e-Consent Framework allows study teams to obtain and document electronic consent through a REDCap survey. When configured appropriately, participants can review consent materials, provide required information and signatures, certify their responses, and generate a saved PDF copy of the completed consent documentation.

Important Compliance Reminder

Before using REDCap for e-Consent, study teams should discuss the proposed consent process with the IRB and confirm that electronic consent is appropriate for the study. REDCap provides the framework and documentation tools, but the study team is responsible for building, testing, and obtaining approval for the consent process.

FDA-regulated studies: UConn Health’s current REDCap production instance is not validated for 21 CFR Part 11 compliance. Studies requiring Part 11–compliant electronic records or electronic signatures should not use the current production REDCap instance for that purpose.

What the e-Consent Framework Does

The e-Consent Framework adds two important steps to the normal REDCap survey process:

  • Certification page: Before the survey is submitted, participants are shown a PDF-style copy of their responses and must certify that the information is correct.
  • Automatic PDF documentation: After completion, REDCap saves a static PDF copy of the signed consent documentation in the project’s File Repository.

These features help create a documented consent record, but they do not replace the need for IRB approval, careful project design, testing, and appropriate study-team procedures.

Before You Build an e-Consent Survey ▼
  • Confirm with the IRB that e-Consent is acceptable for the study.
  • Use the IRB-approved consent language and stamped consent form, if applicable.
  • Determine who needs to sign: participant, parent/guardian, legally authorized representative, study staff, investigator, or others.
  • Decide whether the consent will be completed remotely, in person, or both.
  • Confirm whether the study requires 21 CFR Part 11 compliance.
  • Plan how the completed consent PDF will be reviewed, accessed, and retained.
Recommended e-Consent Setup Steps ▼
  1. Enable surveys for the REDCap project.
  2. Create the consent instrument in the Online Designer.
  3. Add required fields such as participant name, date of birth if needed, and signature field.
  4. Enable the instrument as a survey.
  5. Select e-Consent and PDF Snapshots from the Online Designer.
  6. Enable the e-Consent Framework for the appropriate survey.
  7. Configure the e-Consent settings, including signature fields, PDF naming, and PDF storage options.
  8. Add the approved consent form as a new consent version.
  9. Test the full workflow as a participant before moving to production.
Consent Form Versioning ▼

REDCap allows study teams to add consent versions so that the correct version of the consent form is displayed and documented. Once a REDCap e-Consent version number is used, it cannot be reused. Study teams should maintain clear version control between the IRB-approved consent document and the REDCap e-Consent version.

PDF Snapshots and Storage ▼

When e-Consent is enabled, REDCap automatically saves a PDF copy of the completed consent documentation to the project’s File Repository. Study teams may also configure PDF snapshots to save to a file upload field or to combine multiple forms into a single PDF snapshot when appropriate.

Multi-Signature or Multi-Form Consent Workflows ▼

Some studies may require signatures from more than one person, such as a participant, parent or guardian, legally authorized representative, or study staff member. These workflows should be planned carefully. In some cases, separate instruments may be needed for different signing roles, and additional PDF snapshot triggers may be used to combine multiple signed forms into one saved PDF.

Testing Checklist ▼
  • Test the survey link from the participant perspective.
  • Confirm that the consent form displays correctly on desktop, tablet, and mobile when possible.
  • Confirm that all required fields and signature fields work as expected.
  • Complete the certification step and verify that the survey is marked complete only after certification.
  • Open the generated PDF and confirm that the consent content, signatures, dates, and footer information appear correctly.
  • Confirm that the PDF is saved in the expected location.
  • Test all branching logic, DAG-specific consent versions, and Multi-Language Management settings, if used.