Portal de Periódicos da CAPES

As demandas administrativas de um centro de pesquisa clínica no Brasil

2023; Hospital de Clinicas de Porto Alegre ; Universidade Federal do Rio Grande do Sul (UFRGS); Volume: 43; Issue: 3 Linguagem: Inglês

10.22491/2357-9730.126490

2357-9730

Carolina de Lima Alves, Dario Fausto Saba, Heveline Rayane Moura Roesch,

Public Health in Brazil

Clinical research sites are healthcare institutions that have the capacity to conduct clinical studies on experimental drugs.This performance is done in accordance with the legislation of each country's regulatory agency and with the international scientific standard of Good Clinical Practice, the latter through directive documents such as the Good Clinical Practice (GCP) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the American's Document, established by the Pan American Health Organization (PAHO).Among the demands of site research, the appropriate disposal of residuals, especially of the used or unused investigation product, is a constant.Finally, it is concluded that both the regulatory documents (RDC No. 9/2015, RDC No. 506/2021 and IN No. 136/2022) and international directive documents are in line with each other, establishing that legal and functional responsibility of the disposal and final destination of this type of residual falls on the Sponsor of the clinical study, or one similar to it.Thus, this paper aims to discuss the proper disposal of experimental drug by research sites, using a descriptive analysis of national regulatory documents, relating them to documents at an international level.