Good Clinical Practice (GCP) Practice Exam

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What is the primary role of an impartial witness in a clinical trial?

A person who conducts the trial
A person independent of the trial who attends the informed consent process
A person who ensures compliance with regulatory authorities
A person responsible for analyzing trial data

The correct answer is: A person independent of the trial who attends the informed consent process

The primary role of an impartial witness in a clinical trial is to be an independent individual who observes the informed consent process. This person ensures that the consent is being obtained in a fair and unbiased manner, particularly when the participant may have limitations in their capacity to understand the information provided or may require additional support due to language or cultural differences. The presence of an impartial witness serves to protect the rights and welfare of the participant, ensuring they are adequately informed and consenting voluntarily to participate in the trial. This role is especially important in scenarios where the participant might not fully grasp the implications of their consent or may feel pressured to enroll due to the presence of investigators or other trial staff. By having someone independent present, it reinforces the ethical standards of the trial and helps to safeguard the integrity of the informed consent process.