eConsent Best Practices and Compliance Tips

Setting up eConsent in REDCap is just the first step. Making sure your process is compliant — and will hold up under IRB and FDA scrutiny — requires attention to both the technical setup and your team's procedures.

21 CFR Part 11: What You Need to Know

If your study falls under FDA oversight, you'll need to consider 21 CFR Part 11 compliance. REDCap is considered Part 11-ready, meaning that when implemented with appropriate procedures, documentation, and qualification, your study may meet Part 11 requirements.

Compliance requires two components working together:

1. Technical specifications — The software setup, audit trails, access controls, and electronic signature capabilities built into REDCap
2. Operational processes — The procedures, training, validation, and documentation your team puts in place at the project level

Best Practices

• Get IRB approval before building. Always obtain IRB approval for your eConsent before creating it in REDCap. Build from the IRB-approved PDF to ensure consistency.
• Use two-factor identity verification for signatures. To meet Part 11 requirements, use two distinct components to verify participant identity when signing — such as a unique identifier and a generated code.
• Define study team roles clearly. Explicitly document who has what responsibilities and access levels within your REDCap project.
• Train your team. Part 11 requires personnel training commensurate with their responsibilities. Document all training.
• Maintain change control. Document any changes to your database or consent forms, and keep records of why changes were made.
• Plan for record retention. Know how long you need to keep consent records and ensure your system supports that timeline.

Compliance Guides from Universities

• REDCap & eConsent for FDA Studies (Northwestern University) — Detailed guide on Part 11 compliance with REDCap eConsent
• REDCap eConsent Template and 21 CFR Part 11 Compliance (University of Utah CTSI)
• REDCap Part 11 Process & Training (Boston University)
• Is REDCap Part 11 Compliant? (ITHS / University of Washington)
• IRB Tip Sheet: REDCap eConsent (Vanderbilt University Medical Center, 2025)
• eConsent Overview and General Instructions (Boston University Medical Campus)