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ROC 101 – Research for EMS Providers

Study Protocols

A protocol is the master plan for all aspects of a research study. It is a legal document that specifies the population to be enrolled and how the therapy is randomly assigned to patients.  Also, the protocol addresses what data is to be collected and the measures for success.

Before EMS gets the green light to enroll patients in a ROC study, the study protocol is rigorously reviewed and must be approved by at least four independent groups responsible for safeguarding the health and welfare of patients:

• Independent Review of Protocol (Protocol Review Committee)
• Data Safety and Monitoring Board
• FDA and Health Canada
• Institutional Review Board
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