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Clinical Trial Standards

Meaning

Clinical trial standards represent a comprehensive set of ethical, scientific, and regulatory requirements that govern the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of human clinical research. Adherence to these standards, such as Good Clinical Practice (GCP), ensures the credibility and accuracy of the trial data while safeguarding the rights and well-being of the study participants. These formalized guidelines are essential for generating reliable evidence regarding the efficacy and safety of new hormonal therapies or interventions. Non-adherence can compromise the validity of the results and prevent regulatory approval for new treatments.