IDE Monitors Responsibilities

The sponsor is responsible for selecting monitors qualified by training and experience to monitor the investigational study. Monitors may be employees of the sponsor or an organization contracted by the sponsor to perform the duties of the study monitor.

The monitor is responsible for securing compliance with the requirements of the IDE regulation. The monitor must assure that the investigators are complying with the signed agreement, the investigational plan, the IDE requirements, any other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA.

The IDE regulation requires that the sponsor identify the name and address of the monitor and provide written monitoring procedures. While the IDE regulation does not specify the content of the written monitoring procedures, FDA has published a guideline, "Guideline for The Monitoring of Clinical Investigations, January 1988" on acceptable approaches to monitoring clinical investigations involving FDA-regulated products.