Clinical Trial Application (CTA)

A clinical trial application (CTA) is a formal request submitted to the EU/EEA Member States to obtain authorization to conduct a clinical trial involving human participants. It is a key step under the Clinical Trial Regulation (EU) No 536/2014 [CTR], ensuring that clinical trials are safe, ethical, and scientifically robust.

The CTA includes comprehensive documentation such as the clinical trial protocol, the investigator’s brochure, informed consent forms, and manufacturing information for investigational medicinal products. It also provides data on trial design, risk mitigation, and justification for involving human participants. Caution must be exercised when using the acronym „CTA" as this is often used also for „Clinical Trial Authorisation" or „Clinical Trial Agreement"