Argentina

Argentina

National Registry of Health Research (ReNIS)

Verified on September 9, 2021

Argentina does have a national clinical trial registry for a clinical trial disclosure but registration does not appear to be mandatory (compulsory for studies under ANMAT regulation) for all trials. The clinical trial registry of Argentina is the National Registry of Health Research (ReNIS), which was created by the Ministry of Health through Resolution 1480/2011.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
ReNIS Mandatory National Database (includes Ethics Requirement) Competent authority Clinical Trial Application

Interventional

(Phase 1-4);

Observational

Spanish
InfoSalud Mendoza Mandatory National Database (includes Ethics Requirement) Competent authority Clinical Trial Application

Interventional

(Phase 1-4);

Observational

Spanish
Registration and Results Requirements
Registry Activity Legal Requirement Timing
ReNIS Registration

Yes

Prior to first subject enrollment
Results

n/a

Not applicable (NA)
InfoSalud Mendoza Registration

Yes

Prior to first subject enrollment
Results

n/a

NA

Registry Updates


References


  1. Guidance for Investigators to Conduct Clinical Trials / Clinical Trials Data Elements, Resolution 1480/2011. https://leaux.net/URLS/ConvertAPI Text Files/111DB22DA85A4E0B38C0B8DEFECCC623.en.txt. Published on August 13, 2011. Accessed March 26, 2016.
  2. Step by Step Registration Process for Sponsors available on SISA. SISA online help – Sistema Integrado de Información Sanitaria Argentino (msal.gov.ar). Accessed March 26, 2016.