Who oversees the SmartCPR Trial?
The oversight of this study is provided by a number of individuals and groups. The principal investigator, site investigators, sponsor investigator and study coordinators are listed elsewhere in this website (click here). In addition, all clinical trials are required to have an Institutional Review Board (IRB) that is responsible for overseeing the study. The New York City Department of Health has authorized its IRB to serve in this capacity for the SmartCPR Trial. (Click here to find out more about the IRB.) Finally, trials utilizing a waiver of informed consent process are required to have one final layer of oversight. This body, called the Data Safety Monitoring Board, is responsible for periodically reviewing the study data and all events with potential adverse effects to patients. If significant benefit or harm is found during the course of a study, even before its intended stopping point, this body can recommend the early termination of a study.
