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
- June 2022: What’s New on ClinicalTrials.gov - On June 15, 2022, the below update was posted on ClinicalTrials.gov, What’s New section The British Medical Journal (BMJ) has published an article specifying the approaches to report master protocol study designs on ClinicalTrials.gov. A master protocol is a unified study design and operational aspect conducted with a collection of trials or substudies in patients … Continue reading "June 2022: What’s New on ClinicalTrials.gov"
- June 2022: What’s New on ClinicalTrials.gov - On June 09, 2022, the following updates were posted on the Clinicaltrials.gov What’s New section. The new FAQ for the deadline for submitting a good cause extension for prematurely terminated studies have been included and the information to be taken into consideration for registering expanded access records have been updated. A responsible party must submit … Continue reading "June 2022: What’s New on ClinicalTrials.gov"
- May 2022: What’s New on ClinicalTrials.gov PRS Beta Test System - The below update was posted on the What’s New section of ClinicalTrials.gov PRS Beta test system, which will be available on ClinicalTrials.gov PRS Beta by late May, 2022: The following updates, improvements, and bug fixes were made in the different section of the PRS Beta test system Record List Page The release version number was … Continue reading "May 2022: What’s New on ClinicalTrials.gov PRS Beta Test System"
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.