Clinical trial authorization
Regulatory approval to conduct a clinical trial in a specific country.
What it means
Clinical trial authorization (CTA) is the approval granted by a national regulator to conduct a clinical trial in that country. It typically requires submission of the protocol, investigator's brochure, informed consent form, case report forms, and other site materials in the local language. Each country has its own naming and process conventions.
Why it matters for LATAM submissions
CTA approval is the gate to study start-up. Incomplete or inaccurate translations in the CTA package can delay site activation, enrollment, and study timelines.
Relevant regulators
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Related terms
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