Good Clinical Practice

Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical trials.  These important standards assure that data are accurate and importantly, that clinical trial participants are protected. 

GCP is instituted by the International Conference on Harmonization (ICH).

When one joins a biopharma company there are numerous trainings; for physicians in industry, GCP training is one of the key trainings we receive. 

Principal Investigators and other study personnel at clinical trial sites also have to complete GCP training.  

You can find more information on GCP on the FDA website and EMA (European Medicines Agency) website. 

GCP is a critical component to clinical trial conduct – many physicians have some understanding of, or experience with, GCP – it may be from submitting to an IRB (Institutional Review Board) or completing Informed Consent for a patient participating in a study.  

Understanding GCP is helpful for pharma job interviews and critical training you will receive once you’ve landed your first role in biopharma. 

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