Good Clinical Practice

Clinical research is like a foundation stone upon which a tower of evidence is erected which helps in the better understanding of the cause of the disease, improvement in the diagnosis treatment and mechanism of human biology (Trauter,1997). It is only the systematically carried out research which has made possible the increase in the life expectancy and decrease in human sufferings. While carrying out the clinical research one must not treat human as biomachines but the rights, safety and well being of trial subjects should always prevail over the interests of science and society. Clinical trials require quite distinct shift in the attitudes and procedures from ordinary clinical practice insofar as they require proactive approach to patient recruitment, enrolment and follow through as well as significant attention paid to the issue of documentation regulatory compliance and error prevention (Keiv, 1997). Good clinical practice is an international ethical & scientific quality standard for designing , conducting, recording and reporting trials that involve the participation of human subjects (ICH, 1997). All those people who are involved in any type of clinical trial must be aware about the ethical principles that have the origin in the declaration of Helsinki. To investigate the knowledge of these principles concurring the clinical research among researching physicians and to compare this knowledge among the physicians in different research areas a survey based on 22 questions was send to 1000 hospital physicians in the Copenhagen area (Sovensen, 1997). Forty six percent and 304 of these were used for future analysis 821 replied that they had knowledge of good clinical practices nevertheless only 24% were able to recognize the meaning of term "monitor", investigation .and "SOP" when asked about 6 different fictitious situations concerning making reports to an Ethical Review Board (ERB) only 33% replied correctly. This only shows the poor state of awareness about the guidelines of GCP among the researches. A better awareness can not be expected in Indian researches. The guidelines for GCP was developed with consideration of the current GCP of E.Union, Japan and U.S. as well as those of Austria, Canada and nordic countries & WHO. These guidelines-cover almost all the components of a clinical trial such as patient protection, responsibilities of the sponsors, information management, data processing and quality assurance. Observation of these guidelines and stands must be emphasized chiefly for the reasons of publication suitability and the international recognition of the research …