Patient Participation Guide

The cardiovascular (CV) clinical trials coordinated by St. Vincent Cardiovascular Research Institute in Indianapolis provide an opportunity for men and women with heart and vascular diseases to have access to cutting-edge therapies.

A clinical trial candidate or subject is typically a St. Vincent heart or vascular patient with a specific cardiovascular medical diagnosis. Every clinical trial has a very specific purpose and participant eligibility criteria. Your St. Vincent cardiologist or vascular specialist, along with the CVD Research Team at St. Vincent, will evaluate the criteria to determine if you are a candidate for an appropriate research study. By participating in a study, you agree through the informed consent process to have information collected about your specific cardiovascular condition. The medical data help the physician-researchers and clinicians understand more about specific diseases and how to best treat them. A principal investigator is the medical provider who is in charge of a study. The other physicians from.

St. Vincent who are involved in the study are called sub-investigators. The cardiovascular researchers work closely with the clinical research coordinators (CRC) at the St. Vincent Cardiovascular Research Institute to ensure the protocol is followed and that federal guidelines and Good Clinical Practice (GCP) standards are adhered to.

Before a study can be offered to subjects at St. Vincent, it must be reviewed and approved by an Institutional Review Board (IRB), an ethical committee that formally approves, monitors and reviews any biomedical and behavioral research involving human participants. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of all participants in the research study.

Once you are a confirmed participant in a clinical trial, a specific clinical research coordinator (CRC) will help you navigate the experience and is available to get answers to all of your questions at any point in the process.

Information

All of our clinical trials are listed and verified by the U.S. National Institutes of Health and more information can be found at http://www.clinicaltrials.gov.

See a complete listing of all open clinical trials available at the St. Vincent Cardiovascular Research Institute

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