Puerto Rico

Puerto Rico

No Country Specific Registry

Verified on November 15, 2022

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


References


  1.  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.
  2. 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.
  3. Frequently Asked Questions–ClinicalTrials.gov. https://clinicaltrials.gov/ct2/manage-recs/faq#fr_23. Published November 2018. Accessed February 26, 2019.
  4. Sponsors— PRCCI –Puerto Rico Consortium for Clinical Investigation. http://www.prcci.org/sponsors. Accessed February 26, 2019.