Auditing and Monitoring

When:  Feb 15, 2019 from 11:45 AM to 01:00 PM (ET)
Speaker 
Sherri Mizrahy, RN, MSN, CCRC
Compliance Manager 
UF Health Cancer Center

Target Audience
  • CRCs
  • CRAs
  • Investigators
  • Auditors
  • Project Managers
  • Regulatory Affairs/Compliance
  • Data Managers (Site, Sponsor, CRO)
  • Quality Assurance
  • Clinical Research Administrators
Program Description
Auditing and monitoring make up an essential component to ensuring quality clinical trial safety and efficacy. The goal of this program is to educate clinical research staff on the processes, intention and long-term benefits of routine internal and external auditing and monitoring.

Program Agenda
11:45 - Arrival and Sign-in
12:00 PM - Introduction of speaker
12:05 - 12:50 PM - Presentation
12:50 PM - Q&A Session
1:00 PM - Closing remarks

Learning Objectives
  1. Describe the differences between monitoring and auditing processes.
  2. Plan for and manage the process of preparing for an audit / monitoring visit.
  3. List the different types of internal audits conducted by the UFHCC RO Clinical Trials Auditing Team.
  4. Explain how monitoring and auditing processes help to protect the integrity of clinical research.

Location

Cancer Genetics Research Complex
2033 Mowry Road
Gainesville, FL 32610