Clinical trials: Apply for authorisation in UK – MHRA

This is a recently updated guidance that discusses How to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make changes to your application.

This guidance covers the below topics

Contents

1. Clinical Trials and coronavirus (COVID-19)

2. When a clinical trial authorisation (CTA) is needed

3. Trial Sponsor and legal Representative

4. Registration of your clinical trial

5. Ethics committee

6. Clinical trial authorisation application form

7. Documents to send with your application

8. Assessment of your submission

9. Common issues identified during clinical trial applications

10. Change your application before or during assessment

11. Withdraw your request before the final decision

12. Notification scheme

13. Applications that need expert advice

14. Fees

15. Contact

The guidance was last updated on Last updated 24 June 2021