Clinical trial application

In Regulatory & approvals

Also known as: CTA (regulatory), clinical trial authorization

A clinical trial application is the submission requesting permission to run a trial in a given country or region. In the European Union it is made through the Clinical Trials Information System under the Clinical Trials Regulation, giving one application across multiple member states. The equivalent in the United States is the IND.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.