What is Good Clinical Practice?

What is Good Clinical Practice (GCP)? This is a concept that encompasses many principles that can help guide researchers when designing and conducting research. Good Clinical Practice has 13 core key principles, is meant to protect research subjects’ rights, ensure their safety and well-being, and ensure the integrity of research data offering a strong principled code for best practice. This document is maintained by the European Medicines Agency.

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Before Good Clinical Practice was widely adopted, clinical research relied on peer and clinician judgment. This was unacceptable to regulators, so national and international organisations adopted versions of the guidelines. The Declaration of Helsinki, signed in 1964, provided the framework for these guidelines. To find out more about Clinical Training Courses, go to a site like Tidal Training

Good Clinical Practice is a worldwide set of guidelines that ensures the reliability of clinical trials, and protects patients and the public. It includes design, conduct, monitoring, auditing, recording, and analysis. It is used to guide the design and conduct of clinical trials, and is widely accepted. The GCP code is a set of recommendations that are aimed at ensuring that clinical trials are conducted safely and ethically.

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They were developed after consideration of good clinical practices in different countries. The principles of GCP are derived from international standards, regulations, and guidelines. For example, the Declaration of Helsinki emphasises the ethical and medical principles of research, and GCP ensures the integrity of study data in a standardised form across all countries.

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