Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam 2025 - Free ACRP Practice Questions and Study Guide

Question: 1 / 400

What is the purpose of an independent data monitoring committee?

To perform regulatory audits of clinical trials

To assess safety and efficacy during a trial

The purpose of an independent data monitoring committee (IDMC) is primarily to assess safety and efficacy during a clinical trial. This committee plays a crucial role in overseeing the progress of a trial, specifically monitoring the data that emerges regarding the participant's safety and the treatment's effectiveness.

By having an independent group of experts review the data, the IDMC can ensure that the trial is being conducted ethically and that any significant issues regarding participants' safety are addressed immediately. This oversight is critical for maintaining the integrity of the clinical trial and for protecting participants while allowing for the timely modification or termination of the trial if necessary.

The other choices focus on aspects not directly related to the independent monitoring of data for safety and efficacy. Regulatory audits are typically the responsibility of regulatory agencies to ensure compliance with guidelines. Establishing trial protocols and objectives is the role of the study sponsor and the research team rather than an independent committee. Likewise, the administration of clinical trials is generally managed by the study team, not by an independent monitoring body.

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To establish trial protocols and objectives

To administer the clinical trials operationally

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