Good Clinical Practices or GCP are guidelines that cover the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of clinical studies.
Clinical trials are sensitive research processes that can, if handled wrongly, create legal liabilities and ethical issues for organizations. Therefore, companies that need to research the effect and efficacy of newly developed pharmaceuticals or medical treatment on human subjects need to be aware of and compliant with Good Clinical Practices or GCP.
GCP ensures that:
The rights, safety and wellbeing of trial subjects are protected;
The clinical trial data are credible.
Each country has its own set of guidelines for Good Clinical Practices. The International Conference on Harmonization or ICH, which aims at creating a universal set of guidelines for the pharmaceutical industry, has created its own guideline for GCP. This guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).
