The purpose of the Clinical Trial Investigator Series (CTIS) is to provide education on how to successfully conduct clinical trials of drugs, devices, and to some extent, non-drug intervention trials. The intended audience is faculty, residents, or fellows who are, or aspire to be, clinical trial investigators. The modules will focus on different topics related to investigators’ responsibilities when conducting clinical trials. This module focuses on guidance about the federal regulations and UNC-CH procedures for reporting events to the IRB; event reports include reports of Unexpected Problems, Subject Complaints, and Protocol violations. **For faculty and postdocs only**

Presenters:

Charlotte Coley, IRB Training Coordinator, Office of Human Research Ethics (OHRE)

Jeanne Lovmo, Compliance Coordinator, OHRE