subject: GCP- The Essence Of All Clinical Trials [print this page] "Medicine is a noble profession but a damn bad business." This is a very famous quote by Rolleston, Humphrey which points out at the unethical conducts and malpractices taking place under the cover of the great noble profession of Medicine.
In the realm of medical science, clinical trials have become a key instrument in the discovery and invention of new medicines or medical procedures for the betterment of humanity. Clinical research, which is an eminent branch of medical science, determines the safety and effectiveness of medications, medical equipments, diagnostic product and various treatment procedures intended for the use of humans. The continuous growth of the pharmaceutical industry has led to the rising demand for clinical research studies; but at the same time, it has contributed to the rise in the number of clinical trial frauds. Misconduct and fraud are serious offences and can have major impact on the trials, leading to serious and grave consequences as they may put on stake various human lives. It is in the light of regulating such demeaning practices that various regulatory codes and guidelines have been set up for recording, monitoring and analyzing the proceedings and the outcomes of the clinical trial studies. The most important set of such regulatory guidelines is that of GCP- i.e. Good Clinical Practice.
GCP is an internationally qualified standard that has been drafted by the ICH (International Conference on Harmonization) for governing the clinical trials with a set of guidelines that must be followed strictly. These guidelines aim at the protection of human rights in the practice of various clinical trials. They also assure the safety and efficacy of the newly developed medications and treatments. The GCP guidelines set up a framework defining the conduct of procedures, roles and responsibilities of clinical researchers, investigators and the monitors.
GCP is a universally applicable set of 13 core principles which adhere to all clinical investigations affecting the safety and well-being of the human participants. An in-depth study and understanding of these principles is a must for all those associated with the field of clinical research. Even for the students, who are planning to make their careers in this noble profession, a specialized training or course of study of these principles is essential. There are various clinical research courses that provide a thorough knowledge of the GCP requirements for the clinical requirements. They help the students in gaining experience in detecting, correcting and preventing clinical study deficiencies during the course of action.
Courses in Clinical Research also teach them accurate, factual and appropriate documentation procedures so as to avoid all possible un-intentional errors. ICRI Singapore is one such renowned institute which offers a Masters in Clinical Research. It aims at providing the medical, pharmacy and life-science graduates with an advanced understanding of the methodologies and processes required in the practical clinical healthcare applications.
Aim at maintaining the nobility of the unique and dignified profession of Clinical Research by adhering to the guidelines mentioned in the GCP.
