Definition:
A clinical trial application (CTA) is the application or submission to the competent national regulatory authority(ies) for authorization to conduct a clinical trial in a specific country.
It provides comprehensive information about the investigational medicinal product(s) and planned trial, enabling regulatory authorities to assess the acceptability of conducting the study. The health authorities’ assessment focuses on the properties of the investigational medicinal product, the study’s benefit-risk ratio, the quality of the information provided to the trial participants, and the suitability of the clinical sites and investigators.
More information:
Tags: