Cuba

Cuba

Cuban Public Registry of Clinical Trials (RPCEC)

Verified on September 9, 2021

Cuba has a primary registry, Cuban Public Registry of Clinical Trials (RPCEC). It is a World Health Organization (WHO) recognized primary registry. The clinical trials registered on this registry fulfill the criteria for publication of a manuscript in an International Committee of Medical Journal Editors (ICMJE) accredited journals and feed into the WHO International Clinical Trials Registry Platform (ICTRP). It has a provision to register the protocol. In 2019, the National Coordinating Center for Clinical Trials designed and implemented the Results Database of the RPCEC to provide the clinical trials publicly. However, there is no information available regarding results posting in the registry yet.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
RPCEC Countries with their own Registries/Database Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4);

Observational

Spanish
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
RPCEC Registration

No

Prior to first patient enrollment
Results

No

Timeline not specified

Registry Updates


  • 2019: Cuba Regulatory Update - 2019: The National Coordinating Center for Clinical Trials designed (CENCEC) implemented the Results Database of the Cuban Public Registry of Clinical Trials (RPCEC), developed according to the standards established by the World Health Organization (WHO). However, there is no information available regarding results posting in the registry yet. This database may be implemented in the … Continue reading "2019: Cuba Regulatory Update"
  • April 2011: Cuba Regulatory Update - Cuban Public Registry of Clinical Trials (RPCEC) RPCEC was established in June 2007, by the National Coordinating Centre of Clinical Trials (CENCEC). It gained accreditation as a Primary Registry in February 2011 and was incorporated into the WHO International Clinical Trials Registry Platform (ICTRP). The formal announcement was made in April 2011. RPCEC is a … Continue reading "April 2011: Cuba Regulatory Update"

References


  1. RPCEC_Definiciones_2013. https://rpcec.sld.cu/sites/default/files/document/RPCEC_definiciones_2013. Published June 2013. Accessed May 7, 2020.