All interventional protocols require safety monitoring to review accumulated outcome data, including Adverse Event reports to determine whether any of the treatment procedures practiced should be altered or stopped. When evaluating new protocols for data safety monitoring, the type of monitoring required depends upon the size of the study, the nature of the investigation, the complexity of the study design, and the level of risk to study participants. Large, multi-center studies are required to have independent Data and Safety Monitoring Boards to gather and assess study information from all the sites involved in the trial. Local, investigator-originated protocols generally do not need data safety monitoring or a Safety Officer when addressing lesser outcome protocols that involve minimal risk. The IRB reserves the right to designate an independent Safety Officer for investigator-originated protocols to ensure the safety of research participants and compliance with regulations. This IRB also requires all interventional protocols to have a Study Coordinator.

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