What everybody should know about good clinical practices
Abstract
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.
Downloads
Some similar items:
- Daniel Eduardo Henao, Fabián Alberto Jaimes, Evidence-based medicine: an epistemological approach , Biomedica: Vol. 29 No. 1 (2009)
- Luz Elena Velásquez, Catalina Gómez, Erika Valencia, Laura Salazar, Eudoro Casas, Paragonimosis in the peri-urban zone of Medellín, Antioquia , Biomedica: Vol. 28 No. 3 (2008)
- Juan Gabriel Piñeros, Malaria and social health determinants: a new heuristic framework from the perspective of Latin American social medicine , Biomedica: Vol. 30 No. 2 (2010)
- Sandra Milena Arias, Lina Marcela Salazar, Eudoro Casas, Alexandra Henao, Luz Elena Velásquez, Paragonimus sp. in crabs and awareness of the educational community to aquatic ecosystems in La Miel and La Clara, Caldas, Antioquia , Biomedica: Vol. 31 No. 2 (2011)
- Ricardo Andrés Quintero, Carlos Arturo Martínez, Juan Diego Gamba, Isadora Ortiz, Fabián Jaimes, Adherence to international guidelines on early management in severe sepsis and septic shock , Biomedica: Vol. 32 No. 3 (2012)
- Jaiberth Cardona-Arias, Luz Peláez-Vanegas, Juan López-Saldarriaga, Marcela Duque-Molina, Oscar Leal-Álvarez, Health related quality of life in adults with HIV/AIDS in Colombia , Biomedica: Vol. 31 No. 4 (2011)
- Hernán Dario Higuita, Quotation analysis of reference serial publications in Biomédica, journal of the Instituto Nacional de Salud, No.1, volume 15, 1995, to No.2, volume 20, 2000 , Biomedica: Vol. 21 No. 2 (2001)
- Marisol García, Nohora Mendoza, Coordinadores del Programa de Diagnóstico de Malaria, Evaluation of the malaria diagnosis program in the national public laboratory network, Colombia, 1997-1999 , Biomedica: Vol. 22 No. 2 (2002)
- Tania Camacho, Fernando de la Hoz, Victor Cárdenas, Carmen Sánchez, Laura de Calderón, Ligia Pérez, Antonio Bermúdez, Incomplete surveillance of a dengue-2 epidemic in Ibagué, Colombia, 1995-1997. , Biomedica: Vol. 24 No. 2 (2004)
- María Consuelo Miranda, Gloria I. Palma, Ernesto Jaramillo, Ethics review committees for human research: the challenge of strengthening this process in Colombia. , Biomedica: Vol. 26 No. 1 (2006)
| Article metrics | |
|---|---|
| Abstract views | |
| Galley vies | |
| PDF Views | |
| HTML views | |
| Other views | |
