Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials
Track
:
Track 01: Clinical Operations
Program Code:
240
Date:
Tuesday, June 26, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Joan Harley, Training Extension, div. of Pastor Consulting, Inc, United States
Joan Harley, RN, BSN, BS, of Training Extension, div. of Pastor Consulting, Inc. specializes in the development, delivery and management of Training, Mentoring, Competency and eLearning programs. The programs developed have proven to increase productivity, efficiency and compliance within companies.
Senior Medical Officer, Policy and Communication/OSI/OC/FDA. Worked for the Division of Intramural Research/NIAID/NIH as Director, Clinical Safety Office, worked at the Center for the Clinical Trials Network at NIDA/NIH and at the Division of Vaccines and Related Products Applications, CBER.
Graduate of the University of GA College of Pharmacy. Completed Industry Clinical Pharmacy Practice Fellowship at Rutgers University. 19 years as a field-based Clinical Trial Monitor and most recently a Senior Regional Manager in the US Regional Monitoring Network with Hoffmann-La Roche Inc.
Dr. Jules T. Mitchel is President of Target Health Inc., a privately held New York City based full service e*CRO. Dr. Mitchel leads the team at Target Health to develop software tools to enable the "Paperless Clinical Trial, including eSource." Dr. Mitchel has held positions at Wyeth and Pfizer.
Senior Medical Officer, Policy and Communication/OSI/OC/FDA. Worked for the Division of Intramural Research/NIAID/NIH as Director, Clinical Safety Office, worked at the Center for the Clinical Trials Network at NIDA/NIH and at the Division of Vaccines and Related Products Applications, CBER.
Description
The forum will present data collected from the Clinical Trials Transformation Initiative (CTTI) survey on clinical trial monitoring and auditing practices used by organizations to address regulatory requirements, provide a rationale for the re-evaluation of these practices, and summarize new industry trends in the areas of monitoring and auditing of clinical trials.
Learning Objectives: Describe, discuss, and evaluate the current state of monitoring and auditing in clinical research trials Identify the current methods for determining the critical aspects of clinical trials Discuss possible new approaches to clinical trial oversight.