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Session 3A: Round-table: Innovation in Clinical and Safety Monitoring of Clinical Trials

Day & Time:
October 22, 1:30PM - 3:00PM

Type:
Session

Title:
Session 3A: Round-table: Innovation in Clinical and Safety Monitoring of Clinical Trials

Chair(s):
Earl W. Hulihan
C.E.O. and Principal
ew hulihan and associates, inc., United States

Silvia Zieher, MD
Vice President, Latin America Operations
INC Research, Argentina

Description:
The different applicable regulations for the conduct of clinical trials require the sponsors to monitor clinical trials in order to ensure an adequate protection of research subjects rights, safety and welfare as well as to ensure the quality and integrity of the data collected that is going to be submitted with the purpose of marketing applications. With the increased complexity of studies there is a need to improve the efficiency of the monitoring activities as focusing on the most critical data elements using a risk-based approach to monitoring. The standard monitoring practices usually involve onsite visits and 100% source data verification. However, other practices as central and/or remote monitoring and different types of monitoring strategies such as targeted and triggered monitoring have been used with good results and can improve efficiencies in the conduct of clinical trials. Furthermore, the use of computerized systems also offer unique opportunities for data driven decisions and quality oversite. The aim of this session is to explore the innovation being considered in the monitoring of clinical and safety aspects of the clinical trials by sponsors and regulatory agencies as FDA that will certainly drive significant changes in the evolving approach to monitoring activities for the upcoming years.

Presentation(s) & Speaker(s):
FDA Perspective on the Use of New Technologies (via Skype) **FDA participation contingent on U.S. Government ending operations shutdown
Jonathan S. Helfgott
Associate Director for Risk Science, OSI, OC, CDER, DHHS
FDA, United States

FDA Perspective on the Use of New Technologies and Electronic Source Data (via Skype) **FDA participation contingent on U.S. Government ending operations shutdown
Ron Fitzmartin, PhD,MBA
Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER
FDA, United States

Investigator Perspective on the Use of New Technologies and Electronic Source Data
Nelson Kopyt, DO,MD,FACP
Research Director
Northeast Clinical Research Center, United States