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 2021: What’s New on ClinicalTrials.gov PRS - The below update was posted on the What’s New section of ClinicalTrials.gov PRS Test, which will go live on June 27, 2021: Late Results Problem Detection: The Late Results problem notification is now removed upon initial release of results rather than when results are posted. Similarly, the Incomplete Results problem notification is now removed upon … Continue reading "June 2021: What’s New on ClinicalTrials.gov PRS"
- May 2021: What’s New on ClinicalTrials.gov - The below update was posted on the What’s New section of ClinicalTrials.gov, on May 17, 2021: Train-the-Trainer Workshop Application Period is Closed: The application period for the Results Database Train-the-Trainer Workshop for August 2021 is closed. For more information on the workshop go to Training Materials page.
- May 2021: What’s New on ClinicalTrials.gov - The below updates were posted on the What’s New section of ClinicalTrials.gov, on May 11, 2021: Downloading Content for Analysis: The ClinicalTrials.gov Beta API introduced in July 2019 is now the operational API. The Downloading Content for Analysis page has been updated to reflect this change, including links to the current XML schema and crosswalk linking data elements … Continue reading "May 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.