International Congress on Harmonization
The ICH is a regulatory body that brings together all the other minor regulatory bodies in the Europe and America that are in charge of regulating clinical research endeavors. The aim of this union is to have research activities coordinated and harmonized in order to avoid unnecessary duplication of research procedures (Levine, 2011). In the event that the latter occurrence happens, there will be losses in terms of resources, time, and human capacity. Therefore, there is a need to have all the work of the scientists guided by regulations that streamline them with the aim of coming up with distinct yet helpful results. This was the founding principle of ICH.
ICH Guidelines
ICH has four main guidelines on which their activities are directed. These include quality service guidelines, safety guidelines, multidisciplinary guidelines, as well as efficacy guidelines (ICH, 2014). These four guidelines, each spells out distinct procedures that must be undertaken for a sound research procedure to be attained. The provisions of each of the four guidelines mentioned above are discussed below.
Quality service guidelines
Under these guidelines, researchers are required to conduct research in a manner that meets acceptable standards of good quality and safety. How this contributes to harmonization of research makes all the research work be oriented towards achieving some similar set objectives....
International Clinical Harmonisation PROPER SYSTEMS IN PLACE The International Congress Harmonisation WHO Principles of Good Clinical Practice Clinical research is conducted to insure the safety and efficacy of health and medical products and practices (WHO 2002). In the past, randomized controlled trials gave most of the information about the safety and efficacy of these products and treatments. Randomized clinical trials were considered the foundation of evidence-based medicine but reliably only when conducted according to
International Congress on Harmonization Clinical research guidelines There are various bodies that are concerned with the stipulation of guidelines and rules that need to be followed within the medical field and in specific the clinical research areas. The guidelines have been summarized by the International Conference on Harmonization (ICH) into five major areas: those dealing with quality, safety, efficacy and multidisciplinary topics. Within the patient care discipline, guidelines are designed predominantly to
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