Sentinel user reporting pilot to involve 12-20 sites, FDA contractor Coda estimates.
This article was originally published in The Gray Sheet
Executive Summary
FDA SENTINEL USER REPORTING: PILOT STUDY PROTOCOL is in the early stages of development by Silver Spring, Maryland-based Coda. The research firm says it will begin visiting six to 10 hospitals, nursing homes, outpatient centers and ambulatory centers in January to learn more about their device adverse event reporting procedures.