DIA 48th Annual Meeting
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Data Monitoring Committee (DMC): When You Need One and When You Don't!
Track
:
Track 14: Clinical Safety and Pharmacovigilance
Program Code:
213
Date:
Tuesday, June 26, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Barton Cobert, BLCMD Associates, LLC, United States
PRESENTER
(S):
Ethel Kagan
Barton Cobert, BLCMD Associates, LLC, United States Gil Price, Drug Safety Solutions, United States
Description
This session describes what a Data Monitoring Committee (DMC) is, how it is constituted, when it is needed, its duties, responsibilities, charter, actions, interim analyses and consequences of its actions. Ethical issues, complexities, examples and problems will be discussed.
Learning Objectives:
Identify what a data monitoring committee (DMC) is, how it is constituted and what its duties are
Explain how to write a charter for a DMC
Describe how to manage a DMC working with the company's clinical research team and the statisticians Discuss what the consequences are of a DMC's decisions.
Learning Objectives:
Identify what a data monitoring committee (DMC) is, how it is constituted and what its duties are
Explain how to write a charter for a DMC
Describe how to manage a DMC working with the company's clinical research team and the statisticians Discuss what the consequences are of a DMC's decisions.
This session is a part of:
Handout Online
