eConsent
Electronic informed consent delivered on a tablet or web app, subject to the same translation and ethics rules as paper ICFs.
What it means
eConsent replaces paper ICFs with an interactive electronic version, often including videos and comprehension checks. LATAM ethics committees require full translation of on-screen text and any narration, plus a paper backup in the local official language.
Why it matters for LATAM submissions
eConsent screens are often approved as an afterthought. Missing translated captions, tooltips, or comprehension quiz items can force redeployment across every site.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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