[Good clinical practice].
Good clinical practice is the pattern of international standards to assure ethical and scientific quality in the design, conduction and report of studies that involve human beings. These standards are applied in pharmaceutical research, since they came out as regulations to register new medications. Nowadays, they are accepted as standard procedures in clinical research. They are enforced in developed countries since more than a decade and are currently being implemented in Latin America, thanks to an initiative of the pharmaceutical industries. The saturation and high costs of clinical research in Europe and United States, render Latin America as a potential region to conduct clinical studies. FDA, Europe and Japan accept data from abroad, if the studies are conducted following the norms of good clinical practice. It is therefore important that Chilean research centers and researchers become familiar with these norms and be prepared for their implementation.
Mix
H
H
Boehringer Ingelheim Chile y Quintiles Latin America, Clinical Research Organization Chile. hmix@bi.cl
Marovac
J
J
D002985:Clinical Protocols / Q000592:standards*; D017041:Ethics Committees / Q000592:standards; D004992:Ethics, Medical; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D012106:Research / Q000592:standards*
Buenas prácticas clínicas.