Informed consent form (ICF)
The document that explains a clinical trial to participants and captures their voluntary agreement.
What it means
An Informed Consent Form (ICF) is the document that explains the purpose, procedures, risks, benefits, and rights of a clinical trial to prospective participants. In Latin America, ICFs must be translated into local Spanish or Portuguese and adapted for readability, cultural appropriateness, and regulatory requirements. In Brazil, the ICF is called the TCLE.
Why it matters for LATAM submissions
The ICF is one of the most frequently reviewed and rejected documents in a clinical trial submission. Ethics committees and regulators read it closely, and translation errors here can delay study start-up.
Relevant regulators
Related terms
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