DIA 48th Annual Meeting
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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
PRESENTER
(S):
Cynthia Kleppinger, FDA, United States Jennifer Giangrande, Hoffmann-La Roche Inc., United States Jules Mitchel, Target Health Inc., United States Cynthia Zacharias, Celgene Corporation, United States
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.
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.
This session is a part of:
Handout Online
