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Clinical Trial Safety

Meaning

The continuous, meticulous process of collecting, assessing, and analyzing all adverse events and potential risks associated with an investigational drug or medical intervention during its testing in human subjects. This critical function requires strict adherence to ethical principles and established regulatory guidelines, such as Good Clinical Practice (GCP). The paramount objective is to protect the welfare and rights of the trial participants while simultaneously establishing an accurate, comprehensive profile of the intervention’s safety and risk-benefit ratio.