DMC roles and responsibilities

• The primary roles of a DMC are to safeguard the interests of trial participants, preserve the integrity of the trial, and provide sponsor recommendations.

• A fundamental responsibility of a DMC is to make recommendations to the Sponsor concerning the continuation of the study. Most frequently, a DMC's recommendation after an interim review is for the study to continue as designed. Other recommendations that might be made include study termination, study continuation with major modifications, or temporary suspension of enrollment and/or study intervention until some uncertainty is resolved.

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