Good Clinical Practice (GCP)
Good Clinical Practice is a set of guidelines that must be followed when conducting clinical trials to ensure that the rights and wellbeing of the trial participants are protected and that the data generated in the trial is valid. They were developed in the mid-1990s in order to provide clinical trials with a unified standard across the European Union, Japan and the United States, and to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
The GCP guideline is intended for all research, including:
• all types of sponsors, including private, government, university or industry
• all study designs, including randomised clinical trials (RCTs) double-blinded, open-label or comparator
• all study phases, including Phase I to Phase IV trials and
• all investigational products, including new drugs, new indications,
biomedical devices, new methodology or new surgical techniques