title: Brazilian Clinical Trials Registry and the challenges for clinical research governance.
abstract: Over the past five years, efforts to set up a Brazilian clinical trials registry have progressed from early discussions in academic forums through to the establishment of the registry as a web-based computer platform. This article describes the process of developing and introducing the Brazilian Clinical Trials Registry (ReBEC), and its relationship with the authorities that regulate clinical research in Brazil. The Brazilian Clinical Trials Registry and the multilingual, free and open source, internet-based software developed to manage it are outcomes of partnerships among Brazilian federal and international health agencies. Information for describing the technical and operational dimensions of Rebec was drawn from technical documents and the records of the OpenTrials software development team and the ReBEC executive and advisory committees, which are available in free-access repositories. The Brazilian Clinical Trials Registry was launched in December 2010, and approved as a primary registry of the WHO ICTRP network in April 2011. ReBEC's arrival on-line and its acceptance as an ICTRP primary registry is a significant step in consolidating a policy of free access to information on clinical research in Brazil.
authors.affiliation: Instituto de Comunicação e Informação Científica e Tecnológica em Saúde - ICICT, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil. jlaguardia@cict.fiocruz.br
authors.forename: Josué
authors.initials: J
authors.lastname: Laguardia
authors.forename: Alessandro Luís
authors.initials: AL
authors.lastname: Piolli
authors.forename: Margareth
authors.initials: M
authors.lastname: Prevot
authors.forename: Luciano
authors.initials: L
authors.lastname: Ramalho
authors.forename: Ricardo
authors.initials: R
authors.lastname: Gamarski
authors.forename: Claudio
authors.initials: C
authors.lastname: Nishizawa
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration*; D001938:Brazil; D002986:Clinical Trials as Topic; D006801:Humans; D007843:Latin America; D012042:Registries