health, medicine

Good Clinical Research Practices-A Brief Overview

Clinical research is the mandate procedure to establish the safetly and efficacy of specific health or medical products or practices. A series of randomized and controlled clinical trials authenticate vital scientific and health care questions. These trials form the foundation of “evidence based medicine” practice which is based on the principals & standards of Good Clinical Practices. Stringent compliance to Good Clinical Practices (- GCP henceforth) provides public assurance that the safety, rights and well being of research subjects are protected & assured. Conducting clinical research is a strenuous and complex process; hence it requires a number of medical practitioners with a variety of expertise to perform their tasks skillfully and efficiently.

The responsibility of GCP is shared by all the parties involved in the process of clinical research including sponsors, investigators, research organizations, research subjects (those individuals on which research is conducted) and regulatory authorities. WHO – World Health Organization has set 14 universal principles that assure high quality clinical trials. These principles mention that the subjects or individuals involved in the process of clinical trials should be scientifically sound and described in a clear, detailed protocol. It also states that before the research is initiated, any forseeable risks, discomfort or any anticipated benefits for the subject or the society should be clearly identified and supported by adequate clinical or non-clinical information Performa.

According to guidelines provided by WHO, in case the research involves human subjects, it should receive independent institutional board or committee’s favourable approval, prior to initiation of clinical trials. The clinical trials should be conducted in compliance with the approved protocol. The trials must obtain due consent from every subject or legally approved gurdian of the subject. Well qualified medical practitioners / doctors should ensure health and medical care of the trial subjects. The outcomes of trials should be recorded and stored in a way that they support accurate reporting and interpretation of trials. The confidentiality of research outcomes should be maintained in accordance to the confidentiality rules and regulatory requirements.

Today, clinical research is considered as one of the rapidly evolving medical sector. Doctors jobs in the field of clinical research demand excellence in science and technology. One of the key requisite of doctors jobs in the field of clinical research is efficiency at statistics and preferably experience of statically analysis of clinical trials. The field is being equipped well with large patient pool. The trial practitioners must closely follow the advice and guidance of GCP and standard operating procedures to maintain adherence to determine the effectiveness of the company’s quality systems and procedures.