Question

During a monitoring visit, the sponsor discovers that an investigator had used a device in a clinical investigation without obtaining informed consent from the subject. Which of the following should the regulatory affairs professional do?

A. Predate the informed consent with a memo to the site file
B. Contact the patient to obtain the informed consent immediately
C. Ensure that the study director for the sponsor discusses the issue with the investigator
D. Report the protocol deviation to the IRB

Answer 1

When a sponsor discovers that an investigator used a device in a clinical investigation without obtaining informed consent from the subject, the regulatory affairs professional should report the protocol deviation to the IRB.

Step-by-step explanation:

When a sponsor discovers that an investigator used a device in a clinical investigation without obtaining informed consent from the subject, the regulatory affairs professional should report the protocol deviation to the IRB. Informed consent is a crucial ethical requirement in any clinical investigation, as it ensures that participants have full knowledge of the study and voluntarily agree to participate. Failing to obtain informed consent is a violation of research regulations and can have serious consequences.