Resolución 2378 (INVIMA)
Colombia's Ministry of Health resolution defining Good Clinical Practice for institutions conducting research on humans.
What it means
Resolución 2378 of 2008 sets Colombia's GCP standard and the certification framework for research institutions. Translations of foreign-origin ICFs, protocols, and safety documents must be by a MEN-certified Traductor Oficial and consistent with local clinical Spanish usage.
Why it matters for LATAM submissions
INVIMA reviewers reference Res. 2378 in requerimientos. Translation quality that matches its expectations shortens approval cycles.
Relevant regulators
INVIMA
Related terms
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