Colombia

Colombia

No Country Specific Registry

Verified on June 24, 2022

Colombia does not have a clinical trials registry of its own, and hence the trials conducted in Colombia can be registered and results reported on ClinicalTrials.gov as per the Food and Drug Administration Act. It is not a World Health Organization (WHO) recognized primary registry. The clinical trial information posted on ClinicalTrials.gov is available for public view on the portal.

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

Within one year of Primary Completion Date (PCD); Within one year of the last subject last visit for each secondary outcome measure (SOM); Within one year of 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 March 13, 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 March 13, 2019.