title: [Severe adverse effects: evaluation in research protocols used at a university hospital].
abstract: This is a report of the study on incidents cases about severe adverse events from clinical research protocols that were presented to Research Ethic Committee from Hospital de Clínicas de Porto Alegre, RS, Brasil. The adverse events types, classifications and repercussions are presented in a preliminary evaluation from 1543 severe adverse events notified to Hospital in various medicals specialties.
authors.affiliation: Grupo de Pesquisa e Pós-Graduação do Hospital de Clínicas de Porto Alegre e Programa de Pós-Graduação: Ciências em Gastroenterologia da Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil. jgoldim@hcpa.ufrgs.br
authors.forename: José Roberto
authors.initials: JR
authors.lastname: Goldim
authors.forename: Marcia Mocellin
authors.initials: MM
authors.lastname: Raymundo
authors.forename: Gabriela
authors.initials: G
authors.lastname: Marodin
authors.forename: Ana Paula Kurz
authors.initials: AP
authors.lastname: de Boer
authors.forename: Anajara
authors.initials: A
authors.lastname: Gazzalle
mesh_terms: D002986:Clinical Trials as Topic / Q000009:adverse effects*; D006785:Hospitals, University; D006801:Humans; D012720:Severity of Illness Index