Puerto Rico does not have a clinical trial registry of its own, and hence it requires that trials conducted in Puerto Rico be registered and results reported on the global registry ClinicalTrials.gov as all the research sites in Puerto Rico are regulated by the United States Food and Drug Administration (US FDA).
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| ClinicalTrials.gov | Country requiring/recommending ClinicalTrials.gov use | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 2-4) |
English |
| Registration and Results Requirements | |||
| Registry | Activity | Legal Requirement | Timing |
| ClinicalTrials.gov | Registration |
Yes |
Within 21 days of the first subject enrollment |
| Results |
Yes |
Primary Results - within one year of primary completion date (PCD); Subsequent Results - within one year of the last subject last visit for each secondary outcome measure (SOM); Final Results - within one year of the study completion date | |
Registry Updates
- December 2021: What’s New on ClinicalTrials.gov - On December 22, 2021, ClinicalTrials.gov updated the materials for Modernization and Beta Website webinar: A recording of the December 10, 2021 webinar and slides describing the launch of beta ClinicalTrials.gov and demonstration have been added to the ClinicalTrials.gov Modernization page. This webinar provides an update on the modernization effort and a demonstration of the beta ClinicalTrials.gov website.
- December 2021: What’s New on ClinicalTrials.gov - ClinicalTrials.gov Beta Website On December 08, 2021, ClinicalTrials.gov posted an update announcing the first release of the beta ClinicalTrials.gov website and it can be accessed at: ClinicalTrials.gov beta website. More information on the new features that the website provides can be found at: NLM Technical Bulletin. Also, PRS Beta will be released to the PRS … Continue reading "December 2021: What’s New on ClinicalTrials.gov"
- December 2021: What’s New on ClinicalTrials.gov - Webinar on ClinicalTrials.gov Modernization and Beta Website Demonstration On December 02, 2021, ClinicalTrials.gov posted an update about the Webinar on ClinicalTrials.gov Modernization and Beta Website Demonstration. The webinar would be held on December 10, 2021, from 1.00 to 1.45 pm Eastern Time. The webinar would provide an update on the modernization effort and a demonstration … Continue reading "December 2021: What’s New on ClinicalTrials.gov"
References
- ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies. Clinicaltrials.gov. https://prsinfo.clinicaltrials.gov/definitions.html. Published June 27, 2018. Accessed February 26, 2019.
- ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies. Clinicaltrials.gov.https://prsinfo.clinicaltrials.gov/results_definitions.html. Published June 27, 2018. Accessed February 26, 2019.
- Frequently Asked Questions–ClinicalTrials.gov. https://clinicaltrials.gov/ct2/manage-recs/faq#fr_23. Published November 2018. Accessed February 26, 2019.
- Sponsors— PRCCI –Puerto Rico Consortium for Clinical Investigation. http://www.prcci.org/sponsors. Accessed February 26, 2019.