What must an investigator complete when conducting a study under an IDE?

When conducting a study under an Investigational Device Exemption (IDE), the investigator must complete an investigator's agreement. This agreement is a critical document that outlines the responsibilities and obligations of the investigator in relation to the study, ensuring compliance with regulatory requirements and the protection of the rights and welfare of study participants.

The investigator's agreement formalizes the understanding between the investigator and the sponsor of the study, detailing aspects such as adherence to the clinical trial protocol, adherence to Good Clinical Practice (GCP) guidelines, and the management of data and safety reporting. This agreement is essential for establishing accountability and ensuring that the study is conducted ethically and in accordance with regulatory standards.

While informed consent forms, facility approval forms, and clinical trial protocols are also necessary components of clinical studies, they serve different purposes. Informed consent forms protect participant rights, facility approval forms verify that the site is compliant with local regulations, and clinical trial protocols outline the study design and methodology. However, the investigator's agreement specifically addresses the investigator's role and compliance under the IDE, making it the appropriate choice in this scenario.