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Brazilian Clinical Trials Registry and the challenges for clinical research governance
Author(s) -
Laguardia Josué,
Piolli Alessandro Luís,
Prevot Margareth,
Ramalho Luciano,
Gamarski Ricardo,
Nishizawa Claudio
Publication year - 2011
Publication title -
journal of evidence‐based medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.885
H-Index - 22
ISSN - 1756-5391
DOI - 10.1111/j.1756-5391.2011.01145.x
Subject(s) - clinical trial , the internet , medicine , family medicine , clinical research , cancer registry , environmental health , world wide web , computer science , population , pathology
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.