Today we are looking at the combined review service; from 1 January 2022 all new Clinical Trials of Investigational Medicinal Product (CTIMP) applications will be submitted as combined review.

Combined review means applicants only need to make a single application to both Research Ethics Committee (REC) and Medicines and Healthcare products Regulatory Agency (MHRA); the review will be coordinated to receive a single UK decision.

Don’t forget to check out Today’s Top Tip below!

What are some of the benefits of combined review?

  • A streamlined and efficient application process for Clinical Trial Authorisation from MHRA and REC opinion
  • A single submission application
  • A coordinated review process
  • A single unified request for changes or clarifications from the MHRA and the REC
  • A single communication to confirm the final REC opinion and MHRA authorisation

What should you do now to prepare before your first submission?

  • Register for an account in the new part of Integrated Research Application System IRAS – once registered confirm your account via the email received
  • Check if your organisation is listed in the system – if not you will need to contact helpdesk@myresearchproject.org.uk 
  • Ensure you are aware of the guidance document for step by step instructions on using IRAS.

Top Tip
CTIMP applications must be submitted using a new part of IRAS – once registered log into the system check your profile and familiarise yourself with the new setup.

If you would like to discuss how Fusion Pharma can support you with CTIMP applications, please email us at hello@fusion-pharma-limited.com or phone us on  +44 (0) 203 1379 799.