Good Clinical Practice

Abbreviation: GCP

Definition

Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants.

GCP principles underpin investigator responsibilities, informed consent, monitoring, safety reporting, and data integrity expectations. In the United States, GCP is reflected in FDA regulations and widely used across sponsors, CROs, and research sites. Compliance supports participant rights, safety, and well-being while ensuring that trial results are credible and reproducible. GCP adherence is central to regulatory acceptance and inspection readiness across the development lifecycle.

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