Colombia

Colombia

No Country Specific Registry

Verified on September 7, 2021

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


  • 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


  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.