Meeting the Operational Challenges of Risk-based Monitoring: Investigator and Sponsor Perspectives

Track:
Clinical Operations

Day & Time:
June 26, 10:15AM - 11:45AM

Session Number:
328

Room Number:
206AB

Level:
Intermediate

Type:
Symposium

Title:
Meeting the Operational Challenges of Risk-based Monitoring: Investigator and Sponsor Perspectives

Chair(s):
Donna W. Dorozinsky, MSN,RN
President
DWD & Associates, Inc., United States

Description:
This symposium will explore the changing regulatory landscape and novel approaches to risk-based monitoring. Risk-based monitoring puts new demands on the both the sponsor and investigator site. This symposium will offer solutions to meeting some of the many operational challenges of risk-based monitoring. It will also examine the impact of this guidance on the site from both the site perspective and the site monitoring perspective. It will also provide useful tips for successful site management and the identification of high quality sites that are prepared to thrive in this changing regulatory environment.

Learning Objective(s):
Discuss how a well-defined quality program can assist the investigator site in preparing for risk-based monitoring; Discuss strategies for monitoring that reflect a modern, risk-based approach; Describe an understanding of the challenges and requirements of implementing Central Statistical Monitoring.

Presentation(s) & Speaker(s):
Preparing the Investigator Site for Risk-based Monitoring
Donna W. Dorozinsky, MSN,RN
President
DWD & Associates, Inc., United States

Risk-based Monitoring: The New Regulatory Landscape and Conjectures on the Future of Clinical Trial Execution
Amanda Julie Sax, RN
Senior Director, Integrated Processes and Technologies
Quintiles Transnational Corp., United States

Central Statistical Monitoring in Action
François Torche
CEO
Cluepoints, United States