Data and Safety Monitoring Board

To meet the study's ethical responsibility to its participants, an independent DSMB monitors the conduct of the study. The board consists of cardiothoracic surgeons, cardiologists, biostatisticians, ethicists and neurologists, appointed by the NHLBI, who have no formal involvement or conflict of interest with the study subjects, the investigators, the DCC or the clinical sites. The Data and Safety Monitoring Board acts in a senior advisory capacity to the NHLBI regarding data and safety matters throughout the duration of the study.

Protocol Review Committee

The PRC is an independent committee, with no formal involvement or conflict of interest with the interventions evaluated, the investigators, and the DCC. The PRC is responsible for reviewing CTSN protocols and making recommendations to the NHLBI regarding the scientific merit, congruency with the NHLBI’s mission, and feasibility. All CTSN protocols that are not otherwise reviewed by independent and equivalent peer review, must be reviewed and approved by the Protocol Review Committee.

Network Chairs

CTSN leadership is composed of a chair, a senior vice chair, a vice chair for cardiology and a vice chair for Diversity, Equity and Inclusion.

Steering Committee

The Steering Committee provides the overall scientific direction for CTSN. This Committee includes representatives from all participating countries. The responsibilities of the Steering Committee are to: (a) maintain contact with study investigators to ensure high quality data collection; (b) approve and implement major protocol changes in response to recommendations by the DSMB; (c) collaborate in data analysis, interpretation, and publication; (d) establish criteria for authorship on all manuscripts, publications and presentations that arise from the study.

Clinical Centers

CTSN conducts multiple trials with qualified clinical sites that participate in the development of the study protocols and conduct of the studies. All CTSN clinical centers consist of experienced heart teams, comprised of cardiac surgeons, cardiologists, and neurologists, in the US, Canada, the UK, Brazil, and Europe.

Data and Clinical Coordinating Center (DCC)
and International Clinical Coordinating Centers

The International Center for Health Outcomes and Innovation Research (InCHOIR) at the Icahn School of Medicine at Mount Sinai in New York City, functions as the Data and Clinical Coordinating Center for CTSN.

InCHOIR’s investigators and professional staff includes experts in clinical trial design and management, biostatistics, information technology, data management, regulatory affairs, safety and pharmacovigilance, administrative and financial management, and regulatory affairs.

In collaboration with investigators and NHLBI program scientists, the CTSN DCC is responsible for developing multiple clinical trial protocols, establishing operational procedures and related materials for trial and study conduct, analyzing data, and interpreting and reporting results.

Linked Clinical Centers

Five Linked Clinical Research Centers receive funding for core infrastructure from the NHLBI and are comprised of a clinical research center and a linked clinical center. These centers serve patients in high disease burden areas and underserved communities. The mission of the Linked Clinical Research Centers is to train the new generation of scientist in cardiology and cardiac surgery through a Clinical and Implementation Research Skills Program.

The Linked Clinical Research Centers dyad are:

• Cleveland Clinic and Ochsner Health System
• Feinstein Institutes for Medical Research at Northwell Health and Dartmouth/Maine Medical Center
• University of Pennsylvania and CHI St. Vincent Infirmary-Arkansas
• University of Southern California and St. Luke’s Mid-America Health Institute
• University of Virginia Health System and West Virginia University

Event Adjudication Committee (EAC)

The Event Adjudication Committee is composed of individuals who are not affiliated with the trial, the clinical sites or the DCC. The Committee consists of experienced clinicians with expertise in cardiothoracic surgery, cardiology, infectious diseases and neurology. The Event Adjudication Committee reviews source documents and adjudicates all trials events.