Brazil

Brazil

Brazilian Clinical Trials Registry (ReBEC)

Verified on September 9, 2021

Brazilian Clinical Trials Registry (ReBEC) is a World Health Organization (WHO) recognized primary registry. Registration of protocol is required to conduct any trial as per the WHO International Clinical Trials Registry Platform (ICTRP) criteria.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
ReBEC Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4);

Observational

English
Spanish
Portuguese
Registration and Results Requirements
Registry Activity Legal Requirement Timing
ReBEC Registration

Yes

After approval, prior to first participant enrollment
Results

No

The final report should be submitted within 12 months of the clinical trial end date

Registry Updates


References


  1. RESOLUTION -RDC No. 9. Clinregs. https://clinregs.niaid.nih.gov/sites/default/files/documents/brazil/ResolutionNo9-English.pdf. Published February 20, 2015. Accessed November 12, 2018.
  2. RESOLUTION -RDC No. 449, amends the Resolution-RDC No. 9, of February 20, 2015. b00b3d31-a0e0-41c4-a35c-7544d652779d (anvisa.gov.br). Published December 17, 2020. Accessed December 31, 2020.
  3. Anvisa’s Regulatory Agenda 2021-2023.
    Agenda 2021-2023 – Portuguese (Brazil) (www.gov.br). Published May 21, 2021. Accessed June 03, 2021.