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 data provider to WHO ICTRP since 2011.

RPCEC allows Cuban sponsors (registrants) to prospectively register their clinical trials as per the requirement of the International Committee of Medical Journal Editors (ICMJE) accredited journals. During its first year, the registry worked only in Spanish and registered 70 trials. However, to become a primary registry of WHO ICTRP, the English trial form was made available in 2008, and submission of both forms, in Spanish and English, to register a new clinical trial became mandatory in August 2008. The trial form on this registry follows the 20 WHO Trial Registration Data Set (TRDS) items and a set of variables considered by the RPCEC (for example, the approval by the Regulatory agency and the approval by Ethics Committees).

RPCEC  registration number is assigned to the study upon registration. Registrants can submit a trial for registration at any time of day on any day of the week to this registry (24 hours a day, seven days a week). If the trial information is not complete the sponsor will receive a notice from RPCEC requesting the amendments. A group of qualified reviewers check the information of the forms and verify the use of adequate technique language and that the data provided in both Spanish and English is consistent. If there are problems with the information detected in the review process, the registrant is contacted for clarification.

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