Good clinical practice -: Overview

Ethical requirements (guidelines) concerning a licit conduct of non-therapeutic and therapuetic research, including clinical trials of new drugs, have been elaborated by several national and international organizations. They aim to ensure the protection of integrity, human rights and dignity of subjects (patients or non-patient volunteers) involved in the research, as well as to secure the high ethos of biomedical research work conducted. The work of the International Conference on Harmonisation (ICH) has resulted in publication of an impressive set of guidelines covering various important aspects of clinical research. The primary objective of the ICH guidelines is to provide a unified standard for the European Union, Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in the respective jurisdictions. The guidelines should be followed especially when generating clinical trial data that are intended to be submitted to regulatory authorities. The principles established in the guidelines, however, may also be applied to other clinical investigations that may have an impact in the safety and well-being of human subjects. According to the ICH Guideline, the Good Clinical Practice (GCP) refers to an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The realization of GCP in conduct of a clinical drug trial or other research is possible only as a 'concerted action' of all parties involved in this complex and important process. The key issue is to ascertain, that all partners in GCP do understand, respect and fulfill their respective tasks and responsibilities.