The Establishment and Operation of a Data Monitoring Committee

Why should you take this eConference?
Has the FDA required you to establish a Data Monitoring Committee (DMC) for your upcoming investigational clinical trial? If so, how do you proceed? What is a DMC and when is it in your best interest to have a DMC oversee your trial? If you have a DMC, how should it operate and how should your company interact with the DMC? What should be the qualifications of your DMC members? How do you respond to DMC recommendations for your ongoing clinical trial? What type of documentation should be in place for the DMC? If you have had to ask yourself any of these questions, this eConference will be helpful to you and your organization.

You will learn:
-  The definition of a Data Monitoring Committee
-  The difference between a Data Safety Management Board (DSMB) and a Clinical Events Committee (CEC)
-  How to determine if a DMC is appropriate for your clinical trial
-  How to recruit and qualify DMC members
-  What is meant by the “independence” of a DMC
-  The roles and responsibilities of a DMC
-  The proper role of a chairperson on the DMC
-  The proper role of a statistician on the DMC
-  The overall mode of operation of a DMC
-  The recommended contents of a DMC charter
-  The recommended contents of DMC meeting minutes
-  How your company, as sponsor, should interact with the DMC
-  The required documentation for a DMC
-  The relationship of the DMC to the FDA, IRBs and other oversight committees
-  How to respond to the DMC’s recommendations for an ongoing trial

Who should attend:
-  Device Manufacturers
-  Drug Manufacturers
-  Sponsors
-  Clinical Trial Managers
-  Regulators
-  CROs
-  IRBs
-  DMC Members
-  Ethicists
-  Statisticians.

You will receive:
-  Slides
-  References to appropriate guidance documents
-  Sample DMC Charter
-  Sample DMC Meeting Agenda
-  Sample DMC Meeting Minutes
-  CEUs & Certificate

Presenter:
Clinical Device Group is proud to present Steven C. Schurr, Esq. Mr. Schurr concentrates his legal practice in health care law. He has acted as chairperson for several Data Monitoring Committees and has first-hand knowledge in their organization and operation. Prior to becoming an attorney, Mr. Schurr worked as a regulatory affairs and clinical affairs professional within the medical device and pharmaceutical industries. As such, he is highly knowledgeable about the management and execution of investigational clinical trials. You can contact Mr. Schurr at http://www.steveschurr.com

The purchase is $401 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.