Good Clinical Practice (GCP) Practice Exam

Question: 1 / 400

What does the term 'well-being of trial subjects' refer to?

Participants' financial stability

The integrity of subjects' physical and mental health

The term 'well-being of trial subjects' is fundamentally concerned with ensuring that participants in a clinical trial are safe and their overall health—both physical and mental—is prioritized during the study. This encompasses a range of ethical responsibilities that researchers have towards participants, including the need to monitor and manage any adverse effects that may arise from participation in the trial. This consideration is essential in adhering to the principles of Good Clinical Practice, which emphasize the importance of respecting and protecting the rights and welfare of trial subjects throughout the research process.

Protection of participants involves not only preventing harm but also ensuring that they are informed and capable of giving consent, thereby maintaining their autonomy and well-being. By focusing on the integrity of subjects' health, the research ensures that the study can proceed ethically and responsibly, thereby building public trust in clinical research as a whole.

Other options, such as financial stability, trial success rate, or the completion of trial phases, while potentially relevant to aspects of clinical research, do not directly address the specific concerns about the health and safety of individuals participating in a trial. These aspects do not inherently promote or protect the well-being of the trial subjects themselves.

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The trial's success rate

The completion of trial phases

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