What does "Good Clinical Practice" (GCP) refer to?

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Good Clinical Practice (GCP) refers to an international quality standard for conducting clinical trials that is designed to ensure the safety, integrity, and reliability of clinical data. This set of guidelines is essential for protecting the rights, safety, and well-being of trial participants and is recognized globally. GCP outlines the responsibilities of sponsors, investigators, and institutional review boards, which helps promote consistent ethical and scientific quality in the design, conduct, recording, and reporting of clinical trials.

This standard applies to all countries that have adopted GCP guidelines, ensuring that data from clinical trials can be trusted and used by regulatory authorities to make approval decisions regarding new medical products. By adhering to GCP, researchers can provide assurance that the trial results will be credible and can lead to valid conclusions about the efficacy and safety of a clinical intervention.

While the other options touch on aspects of clinical research, none encapsulate the broad and essential role that GCP plays in establishing a unified framework for ethical and scientific rigor in clinical trials.

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