RDC 9/2015
ANVISA's resolution governing clinical trial registration and conduct in Brazil.
What it means
RDC 9/2015 is ANVISA's resolution that establishes the rules for clinical trials in Brazil, including registration requirements, ethics committee review, safety reporting, and inspection. It defines the documentation and language expectations for submissions involving human subjects.
Why it matters for LATAM submissions
RDC 9/2015 is the foundational rule for Brazilian clinical trials. Translation teams must understand what it requires so that protocols, consent forms, and safety reports are submitted in the right format with the right language.
Relevant regulators
Related terms
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