Introduction on Good Clinical Practice

Clinical Research is the key to the discovery of latest diagnostic methods and to develop modern drugs for treatment of diseases. As the guiding ethical code GCP is primarily known for its edict to do no harm to the patients. The complexities of modern medicine research necessitate a more elaborate set of guidelines that address a physician’s ethical and scientific responsibilities such as obtaining informed consent or disclosing risk while involved in Biomedical Research.

Good Clinical Practice is a set of guidelines for biomedical studies which constitute the design, conduct, termination, audit, analysis, reporting, and documentation of the studies involving human subjects. The fundamental principle of GCP is in research on man, the interest of science and society should never take precedence over considerations related to the well being of the study subject. It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical substance under investigation are properly documented. The guideline seeks to establish two cordial principles:

· Protection of the rights of human subjects.
· Authenticity of Biomedical data generated.

These guidelines have been evolved with consideration of WHO, ICH, USFDA and European GCP guidelines as well as the Ethical Guidelines for Biomedical Research on Human Subjects issued by the Indian Council of Medical Research. They should be followed for carrying out all biomedical research in India at all stages of drug development, whether prior or subsequent to product registration in India.