About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Senior Quality Assurance & 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.

Procedures should be in place at the second institution for rapidly identifying test drugs and devices (e.g. an emergency contact number and unblinding procedure). Assuming that the hospitalization at the second institution is medically necessary and that the local physician has determined that it is appropriate to continue the subject (now patient) on the test drug, the second institution is providing incidental medical care and is not participating as a research site.  

Therefore, staff at the second institution are not investigators and the IRB does not need to review the protocol. The usual procedures for dealing with drugs prescribed out-of-facility would be followed (often, this is a pharmacy department policy). The investigator at the original institution remains responsible for test drug administration and follow-up and therefore, should be aware of the hospitalization. The study investigator may need to report the event as an unexpected adverse incident, if it is possibly related to use of the test article. The original IRB remains the IRB of record.

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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