Good Clinical Practice (GCP) Practice Exam

Question: 1 / 400

What is the role of an Independent Ethics Committee (IEC)?

To provide funding for the clinical trial

To monitor the trial's marketing strategy

To offer judgments and advice on ethical issues in the trial

The role of an Independent Ethics Committee (IEC) is primarily to offer judgments and advice on ethical issues related to clinical trials. This committee plays a critical role in protecting the rights, safety, and well-being of trial participants. By reviewing study protocols, informed consent documents, and any related materials, the IEC ensures that the trial is conducted in accordance with ethical standards and regulatory requirements. They assess potential risks and benefits to participants and determine whether the research is ethical and justifiable.

The focus of the IEC on ethical evaluation is crucial to maintaining public trust in the clinical research process, as well as ensuring compliance with Good Clinical Practice (GCP) guidelines. Their independent nature helps to ensure that decisions are made free from any potential conflicts of interest that may arise from sponsors or researchers.

The other options do not align with the primary responsibilities of an IEC. For instance, providing funding and approving budgets are financial and organizational aspects, while monitoring a trial's marketing strategy is more related to regulatory and promotional activities than to ethical considerations. Therefore, the correct answer highlights the essential purpose of the IEC in upholding ethical standards in clinical research.

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To approve the trial's budget

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