Skip to main content

Clinical Trial Application

Meaning

A Clinical Trial Application (CTA) is a formal, comprehensive document submitted to a national or international regulatory authority, such as the Food and Drug Administration, requesting authorization to initiate human testing of a novel drug, biologic, or medical intervention. This submission details the preclinical safety data, the proposed clinical protocol, the manufacturing information, and the ethical plan for patient enrollment and oversight. Securing approval of the CTA is the mandatory gateway to the human clinical research phases.