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Clinical Trial Application (CTA)

Meaning

A Clinical Trial Application, commonly abbreviated as CTA, is a formal regulatory submission required by national health authorities before a sponsor can commence a clinical study involving a new investigational medicinal product in human subjects. This extensive document comprehensively details the proposed study protocol, the chemistry and manufacturing control data for the drug substance, and all available preclinical safety and efficacy data. The CTA serves as the official request for permission to begin the first phase of human experimentation, ensuring scientific rigor and patient safety.