Good Clinical Practice (GCP) Practice Exam

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What does the Data-Monitoring Committee recommend to the sponsor?

Whether to modify financial aspects of the trial
Whether to continue, modify, or stop the trial
Whether to recruit additional participants
Whether to change the trial protocol entirely

The correct answer is: Whether to continue, modify, or stop the trial

The recommendation from the Data-Monitoring Committee to the sponsor is focused primarily on the integrity and safety of the trial. The Committee's role is to oversee the evolving data collected during the trial, assessing the safety and efficacy of the treatment being tested. This involves making informed recommendations as to whether the trial should continue as planned, require modifications based on emerging data, or be stopped due to concerns about participant safety or insufficient efficacy. The Committee does not typically engage with financial aspects of the trial, nor do they make decisions about recruiting additional participants or completely changing the trial protocol. Their main concern is to ensure the ethical conduct of the trial and the welfare of the participants, balancing risks and benefits based on the data collected. Thus, their recommendation is crucial for the overall direction of the clinical study and supports maintaining high standards of Good Clinical Practice.