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?

The choice to ensure that the study director for the sponsor discusses the issue with the investigator is correct because it addresses the serious nature of the deviation regarding informed consent. Informed consent is a critical regulatory requirement and ethical obligation in clinical trials, as it ensures that participants are fully aware of the procedures and risks associated with the study before they agree to take part.

The involvement of the study director is essential because they are often responsible for overseeing the ethical conduct of the clinical investigation and ensuring compliance with regulatory requirements. By facilitating a discussion between the study director and the investigator, any underlying issues can be addressed, corrective actions can be taken, and measures can be put in place to prevent future occurrences. This approach maintains the integrity of the study and protects the rights of the participants.

Promptly reporting this deviation to the Institutional Review Board (IRB) is also a crucial step in ensuring participant safety and maintaining compliance with regulatory standards. However, the action taken by the regulatory affairs professional to initiate direct communication between the study director and the investigator emphasizes the need for immediate assessment and resolution of the situation.

Effective management of this situation is key to upholding ethical standards in clinical trials, and it requires a structured response that emphasizes communication and oversight.