Electronic Data Capture (EDC)
The software system used to collect clinical trial data electronically, replacing paper CRFs.
What it means
EDC platforms host eCRFs, edit checks, and query workflows. LATAM sites expect Spanish or Portuguese interface language for coordinators, and any subject-facing screens (ePRO, eConsent) must be validated per country.
Why it matters for LATAM submissions
Untranslated edit-check messages create query storms at LATAM sites, slowing data cleaning and inflating study costs.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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