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.
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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 firstname.lastname@example.org
- Ensure you are aware of the guidance document for step by step instructions on using IRAS.
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.