U.K. Clinical Trial Application → Components of a CTA Application

Cover letter
Clinical trial application form
Protocol document
Investigator’s brochure (IB)
Investigational medical product dossier (IMPD)
Non-investigational medicinal product dossier (if required)
Summary of scientific advice obtained from the MHRA or any other regulatory authority, if available
Manufacturer’s authorization
Copy of the UK or EMA’s decision on the paediatric investigation plan, if applicable
Content of the labelling of the investigational medicinal product (IMP)

Example table that could be used to help develop the protocol and may be submitted with the CTA application: