TCLE
Brazil's informed consent form, the Termo de Consentimento Livre e Esclarecido.
What it means
TCLE (Termo de Consentimento Livre e Esclarecido) is the Brazilian Portuguese informed consent form used in clinical trials. It is reviewed by the site's Comitê de Ética em Pesquisa (CEP) and, for multicenter or specific-topic trials, by CONEP. The TCLE must be written in clear, understandable Portuguese and accurately reflect the risks, procedures, and rights described in the protocol.
Why it matters for LATAM submissions
The TCLE is held to a higher readability and rights-language standard than the protocol itself. A literal translation of an English consent is one of the most common reasons for ethics committee rejection.
Relevant regulators
Related terms
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