Clinical Trial Investigator Agreement

A sponsor must also require the examiner to dispose of or return the device, unless doing so would compromise the rights, safety or well-being of a subject. An examiner is responsible for obtaining informed consent in accordance with 21 CFR Part 50. The investigator is responsible for the protection of the rights, safety and well-being of the subjects. An examiner must conduct the investigation in accordance with the agreement signed with the sponsor, the test plan, the IDE rules and other applicable FDA rules, as well as any conditions of approval imposed by an IRB and the FDA. . . .