How to Set up Data Monitoring Committees (DMCs / DSMBs) and what is effect on the Drug Development (Clinical Training)
Venue: Online Event
|Event Date/Time: Dec 14, 2010||End Date/Time: Dec 14, 2010|
Data Monitoring Committees (DMCs, DSMBs) are increasingly seen as an integral part of multi centered trials. They are set-up by the sponsors of this research but impact every level of the process. You will learn how the key to their function is as an unblinded oversight group that is independent and has an absolute absence of any Conflicts of Interest. How the key is the handling of confidential information. You will see how safety monitoring is mandated throughout the regulations (21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices) and depends on the nature of the test agent, the vulnerability of the study population, the length of the study, or the number of sites conducting the clinical study.
The FDA has increasingly recommended and sometimes mandated that a DMC be involved to advise the sponsor regarding subject safety. The "Stopping Rules" are an important element in a DMC function. Learn why the overriding reasons for a carefully selected (no Conflict of Interest) unblinded, independent, statistician controlled DMC is to promote and guarantee human subject safety as well as data integrity.
Areas Covered in the Seminar:
The historical background of why Data and Safety monitoring is essential.
The purpose of the Data and Safety monitoring plan.
The Regulatory requirements for safety monitoring.
Studies requiring a formal Safety Monitoring Committees.
What does the "Charter" of a DMC compose of?
What is the composition and function of a DMC?
What types of studies "require" a DMC?
Conflict of interest and the DMC.