Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT)
Abstract
During this third tear of the project our efforts have continued to focus on the regulatory aspects of this compleclinical trial. We communicated directly with regulatory experts in the US Army and local Institutional Review Boards (IRBs) at the University of Pittsburgh and the University of Maryland. We have successfully obtained an Investigational Device Exemption from the FDA Center for Devices and Radiological Health Office of Device Evaluation. We subsequently received approval of the proposal from the University of Pittsburgh Institutional Review Boards (IRB) as the coordinating center for the trial. We now have approval for the study enrollment, pending community consultation and public disclosure, from the IRBs at the Universities of Pittsburgh and Maryland. The Independent Data Safety and Monitoring Board for this trial has been formed and conducted its first meeting by conference call in December 2008. We are now working with the Human Research Protection Office to complete the information for the formal Department of the Army review.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2010
- Accession Number
- ADA606297
Entities
People
- Patrick M. Kochanek
- Samuel A. Tisherman
Organizations
- University of Pittsburgh