What is the role of the Investigator in a clinical trial under an IDE?

The role of the Investigator in a clinical trial under an Investigational Device Exemption (IDE) is fundamentally centered on ensuring compliance with ethical guidelines and regulations. This responsibility encompasses a broad range of activities aimed at protecting the rights and welfare of participants, as well as ensuring that the study is conducted in accordance with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.

Investigators are tasked with obtaining informed consent from study participants, which is a critical step in upholding ethical standards in clinical research. They must ensure that participants are fully informed about the study's purpose, procedures, risks, and benefits before agreeing to participate. Additionally, the Investigator monitors the trial's progress, ensuring that it adheres to the approved protocol and applicable regulations.

By prioritizing ethical compliance, the Investigator plays a crucial role in maintaining the integrity of the trial, protecting participants, and ensuring the validity of the trial's results. This aspect is essential for upholding public trust in clinical research and advancing medical knowledge responsibly.