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What happens when a study subject at one institution is admitted to a second institution that is designated as an extension of the research milieu?

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About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Regulatory Affairs Manager
Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process.

In this instance, the second institution is responsible for a portion of the research protocol. A physician at the second institution should have been identified in the protocol as a sub-investigator for subjects residing in that local catchment area. As sub-investigator, this physician is responsible for conducting examinations of subjects to monitor status and measure effects of the test drug (data collection). These research data are systematically reported to the study investigator.

Because the second institution is conducting research, it is responsible for complying with the applicable research regulations. The IRB at the second institution may review, approve and be responsible for monitoring the portion of the research conducted at there just as it would for any other research in the facility or, it may agree to accept the original IRB as the responsible IRB. If the original IRB is to accept responsibility for other sites, it should consider the rationale for transferring or referring subjects to another institution; the circumstances under which responsibility will be shared; the instructions that will be given to the sub-investigators; the monitoring procedures that will be followed; and the informed consent process.

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