Knowing which 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 Cuban Public Registry of Clinical Trials (RPCEC). Here is an overview of this registry:
Registry name: Cuban Public Registry of Clinical Trials (RPCEC)
Country: Republic of Cuba
Year established: 2007
Points of interest:
- The RPCEC was established by the National Coordinating Center of Clinical Trials (CENCEC), with collaboration from INFOMED – a national health telematics network.
- Registering clinical trials on RPCEC is voluntary and free.
- As established by the World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE), there are mandatory data entry fields in trial forms.
- The RPCEC requires bilingual registration in Spanish and English, and a set of standard operating procedures (SOPs) – audited annually by the CENCEC – are enforced to inform decision-making.
- Users can search the registry by recruitment status, sponsor, registration date, and other advanced search options.
- There are three steps to register a clinical trial on RPCEC:
- Register as a sponsor
- Complete English and Spanish clinical trial registration forms
- Send both forms for review
- Three business days are required to register as a sponsor, and once the forms are submitted the data will be reviewed for consistency and completeness within 15 days.
- The RPCEC asks that all registered clinical trials are updated every one year at a minimum; if not updated within 12 months, any registered clinical trials become listed as outdated.
Related transparency research/articles:
- Cuba’s National Clinical Trials Coordinating Center: Emergence, Evolution, and Main Results
- The ABCs of Clinical Trials in Cuba
- International Clinical Trials Registry Platform—RPCEC
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