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
- November 2022: What’s New on ClinicalTrials.gov - On November 17, 2022, the below update was posted on ClinicalTrials.gov, What’s New section: ClinicalTrials.gov Beta Website: New search features, Improvements and bug fixes are added to make the ClinicalTrials.gov Beta website more user-friendly. The key features include: In addition to expanded tabular view of search results, the card view of search results is also … Continue reading "November 2022: What’s New on ClinicalTrials.gov"
- November 2022: What’s New on ClinicalTrials.gov PRS Beta Test System - The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on November 10, 2022: Updates have been made to the PRS Test system to include two modules in the Protocol Section. These redesigned modules include on-demand help tips and guidance to make the data elements more understandable. The key … Continue reading "November 2022: What’s New on ClinicalTrials.gov PRS Beta Test System"
- October 2022: What’s New on ClinicalTrials.gov - On October 06, 2022, the below update was posted on ClinicalTrials.gov, What’s New section: Webinar on ClinicalTrials.gov Modernization and Beta Website Progress The webinar will be held on October 27, 2022, from 1.00 to 2.00 pm Eastern Time. It will provide an update on the progress of the modernization effort and an overview of the … Continue reading "October 2022: 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.