AnIndependent Data Monitoring Committee (IDMC or DSMB)is a group of independent experts established to review accumulating safety and efficacy data during a trial. Their main role is to ensure subject protection and trial integrity.
ICH E6(R2) 5.5.1:“The sponsor may consider establishing anindependent data-monitoring committee (IDMC)to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.”
Thus, DSMBs/IDMCsdo not perform trial approvals (A),do not design trials (C), anddo not select investigators (D). Their authority is strictly advisory, providing recommendations to sponsors about safety and whether continuation of the study is ethically justified. The sponsor makes the final decision, but DSMB recommendations are highly influential.
Therefore, the correct answer isB (Recommendations to stop a trial).
[References:, ICH E6(R2), §5.5.1 (Independent Data Monitoring Committees)., ]
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