As clinical trials move toward decentralized and hybrid models, the traditional paper-based informed consent process is being replaced by digital solutions. This webinar provides an in-depth exploration of Electronic Informed Consent (eConsent)—the use of electronic systems and multimedia to convey study information and document consent.

Based on the FDA’s latest guidance, this session will teach participants how to move beyond “digital paper” to create an interactive, compliant, and participant-centric consenting experience that reduces regulatory findings and improves retention.

Key Topics to be Covered

Module 1: The Regulatory Landscape

• FDA & OHRP Requirements: Understanding the core pillars of the “Use of Electronic Informed Consent in Clinical Investigations” guidance.
• 21 CFR Part 11 Compliance: Ensuring electronic signatures are legally binding, secure, and auditable.
• IRB/Ethics Committee Expectations: How to present “storyboards” and multimedia scripts for ethical approval.

Module 2: The Participant Experience

• Beyond Text: Using videos, animations, and hover-over definitions to explain complex medical jargon.
• Comprehension Testing: Implementing mandatory knowledge checks (quizzes) to ensure a participant truly understands the risks before signing.
• Accessibility: Addressing the “digital divide” for elderly populations or those with limited tech proficiency.

Module 3: Implementation & Workflow

• Hybrid vs. Remote: Managing consent in-person (on-site tablets) versus fully remote (web-links/video calls).
• The Signature Process: Acceptable methods including biometrics, digital signatures, and username/password combinations.
• Re-Consenting & Amendments: How to efficiently push updates to participants when a protocol changes mid-study.

Module 4: Risk Mitigation & Quality Control

• Audit Trails: Leveraging timestamps to prove that the participant spent sufficient time reviewing the form.
• Data Privacy: Encryption requirements and safeguarding Personally Identifiable Information (PII).
• Common Audit Findings: Learning from FDA warning letters related to “flawed” consent processes.

Who Should Attend?

This session is designed for clinical research professionals who oversee or execute the consent process, including:

• Clinical Operations & Project Managers: To streamline trial timelines and enrollment.
• Quality Assurance & Compliance Officers: To ensure 21 CFR Part 11 and GCP adherence.
• Regulatory Affairs Specialists: To manage IRB/Ethics Committee submissions for digital tools.
• Principal Investigators & Study Coordinators: To improve the site-level consenting workflow.
• Sponsors and CROs: To evaluate eConsent vendors and data integration strategies.
• Data Security & Privacy Officers: To ensure encryption and participant confidentiality.

How to Create a Robust eConsent Framework 

A successful eConsent program is not just a PDF on a screen. Moving beyond a simple “PDF on a screen” requires a strategic approach. This session provides attendees with a practical, six-stage blueprint for developing an eConsent process that satisfies both participant needs and FDA 21 CFR Part 11 requirements. The speaker will explain on how to create an Effective eConsent Process.

According to FDA recommendations, the creation process should follow these steps:

1. Drafting for Accessibility & Compliance
2. Implementing the “Tiered Information” Architecture Master the art of Layered Disclosure.
3. Strategic Multimedia Integration
4. Rigorous Vendor Selection & Validation
5. Executing User Acceptance Testing (UAT)
6. Advanced Identity Verification Protocols

Learning Objectives

By the end of this webinar, attendees will be able to:

• Interpret FDA and global regulations regarding digital signatures and electronic records.
• Design an eConsent workflow that increases participant comprehension scores by up to 40%.
• Defend the use of eConsent during regulatory audits using electronic audit trails.
• Select appropriate technology vendors based on security and scalability needs.

Interactive Element: Live Q&A and Case Studies

The session will conclude with a review of real-world “Rescue Operations” where eConsent was used to fix enrollment bottlenecks in decentralized clinical studies.