Topic: Clinical Research Monitoring of Investigator Initiated Trials (IIT):  Monitoring vs. Auditing and Why They’re Important

 Speakers:        Katie Gannon, MPH, CCRA, CCRC and Rachel Alvey, ACRP-CP

                                Regulatory Knowledge and Support Program

                                Indiana Clinical Translational Science Institute

CME:   1.0

The recording of this offering along with past sessions can be found: CRES Recordings Please note that the current recording may not be posted until 48 hours after the session and CMEs cannot be provided for recorded sessions.

Objectives:

Define the general purpose and importance of Clinical Research Monitoring, key terms and regulations, and Sponsor-Investigator responsibilities. Understand the differences between monitoring, auditing, and DSMBs Describe the different types of monitoring visits and various monitoring visit activities Identify innovations and process improvement in monitoring Introduce the Indiana CTSI Clinical Research Monitoring Program