How Compliance Drives Subject-Centricity in 2024: Patient Engagement and eConsent Impact FDA Audit Preparedness
5thPort On-Demand Webinar

Navigating FDA Audits in 2024: Optimizing Patient Engagement and Consent Compliance

Listen to experts from Advocate Health, Rocky Mountain Clinical Research, Virginia Commonwealth University, and 5thPort as they dive into the state of clinical trial compliance against the dynamic regulatory landscape of 2024.

Uncover how simple, standard, and transparent digital patient engagement and consenting processes enhance accountability, efficiency, better patient education, improve patient accrual (especially minority accrual) and include real-time statistics around diversity consenting.

Key Takeaways:

  1. Gain real-world insights into how to navigate the intricacies and challenges surrounding compliance management – including those related to multiple jurisdictions, languages, and regulatory bodies.
  2. Explore how an effective eConsent strategy can mitigate your compliance risk in on-site, decentralized and hybrid trial activities.
  3. Identify and track key compliance metrics related to patient engagement and consenting.
  4. Learn about preparations you need to make for Diversity, Equity, and Inclusion (DEI) in true patient engagement.
  5. A look inside comprehension testing in the consent process – emphasizing factors like time, context and interactions with patients – that meets IRB and FDA regulations and guidelines.



Dr. Sandy Brooks
Executive Director – Human Research Protection Program,
Virginia Commonwealth University

Dr. Cedron Williams
Chief Research Compliance Officer,
Advocate Health

Heather Judge
Regulatory Specialist/ Research Coordinator,
Rocky Mountain Clinical Research

Suresh Kumar
Senior Vice President – Sales,