Good Clinical Practice (GCP)

Good Clinical Practice (GCP) constitutes an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants, ensuring that studies protect participant rights, safety, and wellbeing while generating reliable, credible data. These comprehensive guidelines established through ICH E6 harmonise clinical research practices globally, covering protocol development, investigator responsibilities, sponsor oversight, data management, and safety reporting.

The biopharmaceutical industry implements robust GCP systems throughout clinical development. Core principles include obtaining informed consent, protecting vulnerable populations, maintaining data integrity through source documentation and audit trails, ensuring investigator qualifications, and implementing safety monitoring. Sponsor responsibilities encompass protocol development, investigator site selection and monitoring, drug supply management, and data quality oversight. Regulatory inspections assess GCP adherence, with findings potentially affecting product approvals. As decentralised trials emerge, real-world evidence gains importance, and patient-centric approaches evolve, GCP frameworks adapt addressing new paradigms while maintaining core principles protecting participants and ensuring data quality.