Cardiac Safety Research Consortium

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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

Use of Remote Monitoring for Cardiac Safety in Clinical Trials

Think Tank and networking event are being rescheduled,
Date: TBD.

This think tank will address issues and questions surrounding the use of remote monitoring (e.g., wearables, monitors, apps)  for cardiac safety in clinical trials.  It will provide real world examples of how different devices are being used, strengths and limitations of remote cardiac safety data,  as well as regulatory expectations for devices used in clinical trials. The think tank will produce a manuscript detailing current best thinking about the proper choice for remote monitoring of cardiac safety depending on clinical trial, patient and device characteristics.

View Full Event Details Here
See Our Meeting Agenda Here

Register Here
Industry Academia Government - CSRC

Balancing efficacy with safety in cutting edge cardiac research for 15 years

Clinical Resources

Featured CSRC Publications

CSRC Member and chair of the Pediatric Cardiology Working Group, Salim Idriss, MD, PhD, recently contributed to two articles related to pediatric cardiac screening.

Detecting Kids’ Broken Hearts—Cardiac Screening Advised During Well-Child Visits | Congenital Defects | JAMA | JAMA Network

First-of-kind Pediatric ECG Data Warehouse for Use in Pediatric Product Development Programs and Prevention of Sudden Cardiac Death in the Young | FDA