Our Mission
The Cardiac Safety Research Consortium advances scientific knowledge on cardiac safety for new and existing medical products by building a collaborative environment based upon the principles of the FDA Critical Path Initiative as well as other public health priorities.
NEWS + EVENTS
Think Tank
Advancing Prospective Cardiovascular Device Clinical Trials Science: Optimizing Ethical Expertise & Efficiency Metrics Through Centralized IRBs
Join us on September 8th 2022 to examine the scientific and ethical rationale of centralized IRBs for prospective multicenter trials of cardiovascular devices. As part of the session, we will develop key metrics of prospective device trials quality, efficiency, cost and value associated with the use/re-use of centralized IRB processes for CV devices; explore the role and operational integration of professional society CV device registries in partnering/facilitating centralized IRB processes/efficiencies in conjunction with registry-supported prospective CV device studies; and explore the potential facilitation of CV device innovation by leveraging centralized IRB infrastructure to provide re-usable repositories of experience and knowledge in areas of unmet clinical need where research includes challenging, nuanced aspects of ethical oversight such as optimizing approaches to informed consent.
You won’t want to miss this session co-planned with MDEpiNet and Clinical Trials Transformation Initiative (CTTI)!
Register today!
