Díaz LN, Hurtado PA, Ríos CMM

Language: Spanish
References: 3
Page:
PDF size: 27.46 Kb.

ABSTRACT

A standard for the conduct of clinical trials and to ensure quality constitute Good Clinical Practice, which are aimed at ensuring publicly protection of subjects participating in the trials and ensure the credibility of the data obtained and based on principles that impact the safety and welfare of the subjects. The "Arnaldo Milián Castro" Surgical Clinical Hospital is inserted into the development of this research in Villa Clara, and it has won prestigious results backed by audits and inspections and achieved records of medical products that follow the standards of Good Clinical Practice.

REFERENCES

1. Organización Panamericana de la Salud. Buenas Prácticas Clínicas: Documento de las Américas. IV Conferencia Panamericana para la Armonización Reglamentación Farmacéutica [Internet]. República Dominicana: OMS; 2005. [citado 7 Nov 2013]. Disponible en: http://www.anvisa.gov.br/medicamentos/pesquisa/buenaspracticas_espanol.pdf

2. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 [Internet]. 59th. Republic of Korea: WMA General Assembly, Seoul; October 2008 [citado 7 Nov 2013]. Disponible en: http://www.wma.net/es/30publications/10policies/b3/17c.pdf

3. Organización Panamericana de la Salud. V Conferencia Panamericana sobre la Armonización de la Reglamentación Farmacéutica [Internet]. Buenos Aires, Argentina: OMS/OPS; Noviembre 2008 [citado 7 Nov 2013]. Disponible en: http://www.paho.org/HQ/index.php?option=com_content&view=article&id=1054:redpanamericana- para-la-armonizacion-de-la-reglamentacion-farmaceutica-redparf& catid=1156:hss-pan-american-network-for-drug-re&Itemid=1685&lang=es