A Visit with Toni Willis, Public Member of ACRP’s Board of Trustees

Blog

Did you know that the ACRP Board of Trustees includes a public member whose role is to champion the public or consumer interest in the drug and device research and development enterprise? They are chosen to bring new ideas and goals to the table, contribute an unbiased perspective, encourage consumer-oriented positions, and offer additional public accountability and responsiveness. We asked Toni Willis, MD, FAAPMR, the current ACRP Public Member, to share some background on her career and how she came to serve in this volunteer role.

Bridging the Monitoring Gap: A Structured Framework for Clinical Quality Management

Clinical Researcher

Independent oversight of research conduct is essential to protect human subjects’ rights and welfare, educate investigators on ethical practices, enhance the ethical review process, safeguard institutions from federal regulatory actions, and maintain public trust in medical research ethics committees. Routine monitoring activities ensure studies are being carried out as intended, while prioritizing the health and safety of the participants. However, federal and foundation-funded projects may not have built-in processes for routine monitoring. To address this gap, Duke University created the Clinical Quality Management Program, which provides a robust framework for clinical research studies, including policies, procedures, and tools that allow clinical research units to effectively monitor without external oversight.

Navigating Protocol Amendments: Understanding the Growing Burden and Charting a Path Forward

Clinical Researcher

Protocol amendments have evolved from an expected operational reality to a defining factor in clinical trial performance, cost, and site sustainability. Across sponsor, contract research organization, and site stakeholders, a consistent message is emerging: while amendments are often necessary, their frequency, timing, and execution are introducing significant downstream inefficiencies. The evidence is clear: protocol amendments are now a system-level challenge requiring coordinated, industry-wide solutions.

Envisioning eConsent Success (Part I): Measuring Operational Impacts at Clinical Trial Sites

Clinical Researcher

An electronic informed consent (eConsent) working group has developed a high-level framework for defining and measuring the impact of eConsent usage at clinical trial sites. This article outlines key success indicators, relevant metrics, and practical steps the industry can take to begin assessing the real-world impact of eConsent on site operations. As eConsent adoption matures, this high-level framework can evolve into a more complex key performance indicator infrastructure.

Envisioning eConsent Success (Part II): Laying Out a Global Interoperability Blueprint for eConsent

Clinical Researcher

An electronic informed consent (eConsent) working group has developed a clear, practical framework that defines the value of integrating eConsent systems with key eClinical technologies. In the companion piece to this article, “Envisioning eConsent Success (Part I): Measuring Operational Impacts at Clinical Trial Sites,” the group defined the different deployment models for eConsent and outlined key stakeholder success measures for using these systems. This article focuses on a technology-agnostic integration blueprint that considers both sponsor-deployed and site-owned systems, and prioritizes both operational feasibility and reduction of duplicate workflows at study sites.