What type of additional information does Quorum Review’s Board need in order to review an international clinical trial conducted outside of the U.S. and Canada?

The Board may take a range of information into account when reviewing international research. You should be prepared to inform the Board regarding the country’s laws regarding human subjects research, other additional pertinent information regarding conducting human subjects research in the country; for drug and device studies, the regulatory status of the product in that country and/or status of research applications held with applicable regulatory authorities, and additional relevant cultural or other local issues about doing research in that setting. The Board also might have specific questions about the country’s geography, economic structure, political system, social/cultural information, and health/medical information as related to the research.