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Re: ou71764 post# 5367

Thursday, 03/06/2014 5:48:22 PM

Thursday, March 06, 2014 5:48:22 PM

Post# of 704323
Steering Committee and Firewalls.

Actually, there may be conversations going on between a steering committee and the DMC.

3.2. Clinical Trial Steering Committees
In some clinical trials the sponsor may choose to appoint a steering committee; this committee may include investigators, other experts not otherwise involved in the trial, and, usually, representatives of the sponsor. A sponsor may delegate to a steering committee the primary responsibility for designing the study, maintaining the quality of study conduct, ongoing monitoring of individual toxicities and adverse events, and, in many cases, writing study publications. When there is a steering committee, the sponsor may elect to have the DMC communicate with this committee rather than directly with the sponsor.

Interactions between the steering committee and the DMC consist primarily of discussions during "open sessions" (see Section 4.3) of DMC meetings and the communication of recommendations following each DMC review of the trial. More extensive interactions might occur when early termination is being considered, or when external forces (e.g., announcement of results of related studies) impact the ongoing trial.

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