Knowing what countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including the Brazilian Clinical Trials Registry / Registro Brasileiro de Ensaios Clínicos (ReBEC). Here is an overview of this registry:
Registry name: Brazilian Clinical Trials Registry / Registro Brasileiro de Ensaios Clínicos (ReBEC)
Year established: 2010
Points of interest:
- ReBEC is an open access virtual platform for registration of ongoing experimental and non-experimental studies on humans performed in Brazil
- It is a joint project of the Brazilian Ministry of Health, the Panamerican Health Organization (PAHO) and the Oswaldo Cruz Foundation (FIOCRUZ)
- 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.
- Study registration at Plataforma Brasil must be completed prior to registering with the ReBEC.
- Before registering a study on ReBEC, have the following documents available – study protocol, PDF copy of the letter of approval from a brazilian ethics committee/institutional review board, and the UTN number
- Learn how to register a trial on ReBEC
News of interest:
TrialAssure® Registry can automate the disclosure of clinical trial results for the Brazilian Clinical Trials Registry. For questions or a free demo, email firstname.lastname@example.org