GCP
Also written as: GCP — Good Clinical Practice
An international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects.
Full Definition
Good Clinical Practice represents the international standard for clinical trial conduct, established by the International Council for Harmonisation (ICH) to ensure trial integrity, data quality, and participant protection. GCP guidelines cover all aspects of clinical research from protocol development through data analysis and reporting. Key principles include scientific validity, participant safety and rights, reliable data generation, and regulatory compliance. In cardiovascular research, GCP compliance is mandatory for regulatory submissions, requiring documented training for investigators and staff, proper informed consent procedures, and comprehensive quality assurance systems. Regulatory inspections assess GCP adherence through review of trial documentation, source data verification, and investigator interviews.
Usage
Usage note: Reference ICH-GCP specifically; distinguish from Good Laboratory Practice (GLP) and other quality standards.
In Context
- "All investigators completed ICH-GCP training before initiating patient enrollment." — Regulatory compliance report
- "The study was conducted in accordance with GCP guidelines and applicable regulatory requirements." — Protocol compliance statement