The University of North Carolina at Chapel Hill
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U.K. Clinical Trial Application → Overview

What is a Clinical Trial Application?

A CTA application from the Medicine and Healthcare Products Regulatory Agency (MHRA) is required for a Clinical Trial of an Investigational Medicinal Product (CTIMP) in order to proceed in to human trials. The CTA is reviewed based on what type of trial is being conducted, which is categorized by human risk level. The timeline for MHRA reviewal can also be based on type of trial, and level of human risk potential as well.

Learning Objectives

  • Describe the three different types of trials based on potential human risk.
  • Detail the MHRA timeline for reviewing and responding to CTAs.
  • Briefly outline the types of MHRA responses and what that means for the trial.
  • List out the components that must be included in a CTA application.