Monitoring and evaluation of adverse events: the experience at Hospital de Clínicas de Porto Alegre

Lucas Wollmann, Verônica Calleya Bittencourt, Ana Paula da Silva Pedroso, Liciane da Silva Costa, José Roberto Goldim


Based on national and international regulations, one of the the Research Ethics Committees (REC) have the attribution to protect human beings involved in research. According to these documents, REC should not only review all the research protocols, but also moni-tor adverse events (AE) reported by the investigator. This monitoring activities must be agile and critical, guiding its actions by evaluation of risk/benefit associated to each study.
The Grupo de Pesquisa e Pós-Graduação of the Hospital de Clínicas de Porto Alegre (HCPA) introduced, in 2001, the Program of Monitoring of Risks and Adverse Events, developed by the Laboratório de Pesquisa em Bioética e Ética na Ciência.


Eventos Adversos; Monitoramento

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ISSN: 2357-9730




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The Clinical & Biomedical Research is licenced under Creative Commons Atribuição 4.0 Internacional.