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Clinical Trial Registry – Brazil
The Brazilian Clinical Trials Registry / Registro Brasileiro de Ensaios Clínicos (ReBEC) is an open access virtual platform for registration of ongoing experimental and non-experimental studies on humans performed in Brazil. ReBEC is a joint Project of Brazilian Ministry of Health, The Panamerican Health Organization (PAHO) and The Oswaldo Cruz Foundation (FIOCRUZ). The Executive Committee of ReBEC is composed of the aforementioned institutions and also The National Health Surveillance Agency (ANVISA).
ReBEC – A publicly-owned, managed by the Oswaldo Cruz Foundation, a research organization in government and nonprofit organizations. All details of the studies reported in ReBEC are publicly available.
According to resolution of ANVISA – RDC 36, of 27 June 2012 amending RDC 39/2008, all clinical phases I, II, III and IV, must show proof of registration of clinical research in the database Brazilian Registry of Clinical Trials – ReBEC, or proof of submission. For cases prior to publication of this resolution will be accepted proof of registration of the researches that have already been recorded in other primary records of the International Clinical Trials Registration Platform (ICTRP / WHO).
For every record there is no cost. The required fields of ReBEC meet the minimum data set required by the International Committee of Medical Journal Editors (ICMJE) and the World Health Organization (WHO). After review and at the time of publication of the study in ReBEC website, the study receives a unique registration number. The responsibility for recording and reporting of studies is the sponsor. The test data will not be removed after they are posted.
The result of a joint effort of the Ministry of Health (DECIT/MS), Institute of Communication and Information Science and Technology in Health (Icict/Fiocruz), the Pan American Health Organization (PAHO) and the Latin American and Caribbean Center on Health Sciences (Bireme), the ReBEC increases the effectiveness of efforts to disclose clinical trial studies public way, reducing publication bias. Thus, the ReBEC becomes an important source of information for patients, health professionals, researchers, companies and research centers, providing greater interaction and international integration.
Scoreboard – Total 3247, there are 971 registered trials, there are 79 in analysis, there are 317 recruiting trial, Total 2851 draft.
Registry URL: http://www.ensaiosclinicos.gov.br
Registration URL: http://www.ensaiosclinicos.gov.br