Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting
clinical trials that involve human subjects. This standard provides assurance that the rights, safety, and well-being of trial subjects are protected and that clinical trial data are credible. Adherence to
GCP is essential for the trustworthiness of clinical research findings and the protection of human participants.
GCP encompasses a broad spectrum of guidelines, including the ethical conduct of research, informed consent, data management, monitoring, and reporting. It emphasizes the importance of independent ethics committees or institutional review boards in safeguarding participant rights and well-being. Moreover,
GCP mandates clear protocols, detailed documentation, and qualified personnel to ensure the integrity of the trial process. By establishing a robust framework for clinical research,
GCP contributes to the development of safe and effective medical interventions while maintaining the highest ethical standards.
Compliance with
GCP is crucial for gaining regulatory approval of investigational products and ensuring public confidence in the clinical research enterprise. It is a cornerstone of ethical and scientific rigor in the pursuit of medical advancements.