ICH E6 (Good Clinical Practice)
The international harmonized standard for the design, conduct, monitoring, and reporting of clinical trials.
What it means
ICH E6 defines GCP internationally. LATAM regulators have adopted it via local instruments (RDC 9/2015, Disposición 6677/10, Resolución 2378, NOM-012). Translation and language obligations are embedded throughout: consent, essential documents, safety reporting.
Why it matters for LATAM submissions
GCP inspections trace deviations back to E6 provisions. Translation-linked deviations map to specific E6 sections that inspectors know by heart.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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