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Cardiac Safety Research Consortium

A Consortium involved in supporting research

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Clinical event adjudication in cardiovascular device trials: An Food and Drug Administration perspective

Posted on June 20, 2017 by kirk.jernigan@duke.edu

American Heart Journal, May 2017

View Paper Here

Andrew Farb, MD, and Bram D. Zuckerman, MD Silver Spring, MD

This entry was posted in reports. Bookmark the permalink.

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← Long-term Electrocardiographic Safety Monitoring in Clinical Drug Development: A Report from the Cardiac Safety Research Consortium
CSRC Meeting & CSRC Think Tank: Detection, Assessment and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development →

UPCOMING EVENTS

SAVE THE DATE

CSRC Pilot Study Training Session

Save the date! We are partnering with Parent Heart Watch for a training session at the 13th Annual Heart-to-Heart Meeting in Savannah, GA on January 12, 2018 at 3 p.m. EST. Registration information and travel information now available.

DIA Annual Meeting

Join the CSRC for a session at the DIA Annual Meeting in Boston June 24-28, 2018.

NEWS & UPDATES

  • Download slides & meeting materials from our October 2017 meeting & think tank
  • Read the new CSRC white paper: “Is There A Role For Pharmacokinetic/Pharmacodynamic Guided Dosing For Novel Oral Anticoagulants?“
  • 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.
    • More Information on the IQ-CSRC Study Waveform Sharing Program

CURRENT PROJECTS

  • CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot Study
  • Enhancing Cardiac Safety though the Use of Social Media
  • *If you would like to get involved, please contact us at cardiacsafety@dm.duke.edu.

SharePoint is now here!

To access SharePoint, just click on the Collaboration Space tab.

Submit your Form for a new QT Project

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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.
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