Risk-Based Monitoring (RBM)
An ICH E6(R2)-endorsed approach that focuses monitoring effort on the highest-risk sites, data, and processes.
What it means
RBM shifts monitoring from 100% source data verification to risk-weighted sampling. Translation quality of ICFs, safety reporting, and protocol deviations at LATAM sites is a natural RBM risk indicator that sponsors track centrally.
Why it matters for LATAM submissions
Translation-related deviations concentrated at specific sites are early warnings that a country ICF was under-adapted; RBM catches them before an inspection does.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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