LEGISLATION AND STANDARDS
Official references that guarantee ethics, safety and quality in our clinical research
Clinical research is guided by ethical and legal standards that ensure the protection of participants, the scientific validity of studies and the responsibility of the institutions involved.
In this section, we gather the main regulatory frameworks that guide the work of NPCRS, ensuring scientific rigor, respect for human dignity and compliance with international best practices.
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Boas Práticas Clínicas: Documento das Américas de 2005
Instrução Normativa n°4 de 2009 Anvisa
Normativa n°21 de 02 de Outubro de 2017
Normativa n°190 de 03 de Outubro de 2017
Normativa n°20 de 2017 de Medicamentos Anvisa.pdf
Resolução da Diretoria Colegiada – RDC n°10 de 20 de fevereiro de 2015
Resolução n°466 de 12 de dezembro de 2012
Good Practice clinical – R2_Adendo_Inglês_2016