Regulatory Enforcement Trends in GCP Violations – Good Clinical Practice (GCP) and Compliance
Good Clinical Practice (GCP) is a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with these standards provides public assurance that the rights, safety, and well-being of trial subjects are protected and that the data generated are credible and accurate. However, violations of these guidelines have been on the rise, leading to increased regulatory enforcement. This article will discuss the major trends in regulatory enforcement concerning GCP violations.
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