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What happens when a study subject at one institution is admitted to a second institution for a reasonably foreseeable reason and as an anticipated part of the study protocol?

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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.

The IRB at the original institution should be aware that other institutions and/or providers will be providing medical care/follow-up and should ensure that adequate reporting and safety systems are in place before approving the study. The protocol should allow the test drug to be sent to the subjects' regular health care providers. Even though the test article is being given at a second institution, only routine medical monitoring is conducted by the local provider with little or no reporting to the study investigator, who remains responsible for the test drug administration and collects research data when the subject returns to the original institution. The involvement of the second institution is incidental to the study (i.e. research data are not collected) and thus, it is not participating as a research site.

Prior to continuing the investigational drug, the local physician should obtain from the clinical investigator the information necessary to safely continue the investigational drug. The information conveyed might include a description of treatment procedures, warnings of possible adverse reactions, emergency procedures, a copy of the signed informed consent document (which is a research summary as well as documentation of consent).

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