Abstract

OSORIO, Lyda. What everybody should know about good clinical practices. Biomédica [online]. 2015, vol.35, n.2, pp.274-284. ISSN 0120-4157.  https://doi.org/10.7705/biomedica.v35i2.2404.

An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.

Keywords : Biomedical research; drug evaluation; clinical trials, ethics research; knowledge management for health research; manuals and guidelines for research management; scientific research and technological development.

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