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Combined review is the way research teams seek approval for new Clinical Trials of Investigational Medicinal Products (CTIMPs) and combined medicine and device trials.
Research teams make a single application using a new part of IRAS, which goes to both the Medicines and Healthcare products Regulatory Agency (MHRA) and a research ethics committee (REC) at the same time. The application also goes for study wide review, such as HRA and HCRW approval, if the study is to take place in the NHS or Northern Ireland HSC.
The regulatory and ethics reviews are done in parallel and any requests for further information (RFIs) are raised jointly. A single response to these requests leads to a single decision from both reviews. Study wide review is usually issued at the same time as MHRA and REC, but may come later if there are still issues to discuss with the applicant.
IRAS is used for the initial application and supports the trial through amendments right up to the end of the trial. Research teams can allocate different roles in the system for colleagues working on the project.
Initial review process and timelines
If there are questions during the review, a ‘Request for Further Information’ (RFI) may be raised and applicants will need to provide additional information or clarifications. Applicants can request an extension if more than 14 days is needed to respond to the RFI, by emailing the MHRA at email@example.com. If more than 14 days is needed, this will affect the 60-day timeline.
For help with tasks in new IRAS, please contact the Service Desk at firstname.lastname@example.org
Quick Start Guide
- First-time user? Contact us at email@example.com for help to get started.
- Check if you need to create an account
- Sponsor and Sponsor Delegate Organisations are selected from options within IRAS - if yours is not listed, contact our Service Desk
- Access early study support and advice services
- Get help with new and ongoing applications with our step by step guide
- We are testing the information in the step by step in another format. Visit our new IRAS user guide today and share your feedback using the short survey
- View our featured video: Combined review for clinical trials
- Read more about the benefits
Further guidance and support
- Pharmacy and Radiation Technical Assurance Submission Guidelines
- Instructions for studies with ionising radiation
- How and when to submit to ARSAC
- Guidance for combined IMP and device trials
- Information on registration of studies
- Current legislation and regulations
- Recorded webinars for applicants, sponsors and NHS/HSC organisations
- REC directory to search meeting dates (filter by RECs recognised to review CTIMPs)
We've produced a short explainer video for newcomers to combined review. Check it out below.