Cardiac Safety


  • Welcome Gilead Sciences, the CSRC's newest Sustaining Member.

  • Registration NOW OPEN for the December 6-7 meeting. Click HERE to register.

Cardiovascular disease is the leading cause of death in the United States, accounting for over one quarter of all deaths every year.

Some medical products intended to treat cardiovascular disease and other diseases have significant and potentially dangerous side effects related to their effects on the heart. Moreover, cardiac safety concerns are a leading cause for the recall of marketed drugs and abandonment of drug development programs for any indication. The Cardiac Safety Research Consortium (CSRC) was launched in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University to support research into the evaluation of cardiac safety of medical products.

CSRC supports research by engaging stakeholders from industry, academia, and government to share data and expertise. Outputs of the CSRC include research projects taking advantage of waveforms released from the FDA ECG warehouse, Think Tank Incubator programs, and consensus white papers. Additional work is under way to expand the portfolio of research projects beyond the ECG data into other areas of cardiac safety evaluation from the preclinical through the postmarket periods.

The CSRC is excited about its past accomplishments and future directions. If you are interested in exploring current opportunities for involvement with the CSRC, please email us at


  • Enhancing Cardiac Safety though the Use of Social Media

  • Development of A Rational, Reliable and Sustainable National Health Care Resource Pediatric Warehouse

  • Development of A Rational, Reliable and Sustainable National Health Care Resource Pediatric Screening Tools/ Processes

  • Restricted Mean Survival Time (RMST) statistical analysis approach for analyzing Diabetes Cardiovascular Outcomes Trials

  • Arrhythmia Normal Limits

  • Combined Holter/12 Lead ECG Analysis



December 6-7, 2016

Registration NOW OPEN: Click HERE

Day 1: Co-Sponsor with HESI

Comprehensive In Vitro Proarrhythmia Assay (CIPA) Update Meeting

The Comprehensive In Vitro Proarrhythmia Assay (CiPA) seeks to markedly transform the assessment of drugs for their proarrhythmic potential, replacing the current focus on ECG QT assessment.  This multi-national effort is moving towards completion in 2017.  This important meeting will bring together stakeholders from industry, academia, multiple regulatory agencies, and CRO’s to discuss the current scientific status of CiPA, how it will impact drug development, and the evolving regulatory framework.  This should be a highly interactive and impactful meeting.

Draft Agenda

Day 2:

Part A: QTc Exposure-Response Modeling Workshop: What is Required?

Part B: Endpoints When Treating VT/VF in Patients with ICDs

To date, there are no widely accepted standard definitions for clinical trial endpoints in the treatment of ventricular arrhythmias in patients with defibrillators. The think tank will endeavor to better define potential single endpoints as well as determine the components of an acceptable composite endpoint. In addition, the inclusion of patient factors, such as psychometric measures and quality-of-life instruments, will also be assessed.

Draft Agenda


Host Hotel Information


February 10, 2017: Pediatric Thinktank on Prevention of Sudden Cardiac Death in the Young: Developing A Rational, Reliable and Sustainable National Health Care Resource

Take a look at our newly published white papers
IQ-CSRC Study Waveform Sharing Program

The IQ-CSRC Study Waveform Data Sharing Program allows interested ECG core laboratories to access a validation dataset to test the ability to accurately characterize QT effects in a manner consistent with the alternative approach to the TQT.

The mission of the Cardiac Safety Research Consortium is to advance regulatory science specifically related to pre-competitive cardiac safety issues through the collaborative means of a public-private partnership across interested stakeholders. The CSRC stands fully ready to encourage, contribute to, embrace and support elements of clinical science such as good scientific design, data analysis, interpretation and dissemination to the public domain within the construct of the resources and committee structure of the public-private partnership forum.

The CSRC does not endorse specific commercial technologies, entities, products, or services.  Any communications to the contrary, written or otherwise, are inaccurate.

*If you would like to get involved,
please contact us at