This page is for researchers using the combined review service in the new part of IRAS. Due to the ongoing development of IRAS, certain types of applications will need information to be completed in both new and standard parts of IRAS as an interim measure. This applies to studies involving ionising radiation or an investigational medical device.

If your study falls into either or both categories, you should read the detailed instructions below which explain how to complete your application. If, after reviewing this page you still have questions regarding your combined review application, you can contact the HRA service desk (service.desk@hra.nhs.uk).

New clinical trials regulations: On 28 April 2025, the UK Parliament and Northern Ireland Assembly approved the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. These new regulations introduced changes to the Medicines for Human Use (Clinical Trials) Regulations 2004 which govern the regulation of clinical trials of investigational medicinal products (CTIMPs) in the UK. The updated legislation came into force  on 28 April 2026. For further information on the changes we recommend you access the dedicated guidance published on the MHRA and HRA website. 

Contents

• Combined Review applications involving ionising radiation.
• Combined Review applications for a clinical trial of an investigational medicinal product and an investigational medical device (IMP/Device trials).

Combined Review applications involving ionising radiation.

If you’re submitting an application involving ionising radiation through the combined review process you should follow these instructions. This guidance is in place as an interim solution until an ionising radiation module is developed and released in the new part of IRAS.

Radiation Assurance for combined review applicants

Radiation Assurance is a pre-submission process. Meaning it occurs before you apply for other regulatory approvals such as a research ethics committee (REC) and the Administration of Radioactive Substances Advisory Committee (ARSAC) reviews.

If your research is a combined review application that requires Radiation Assurance you should ensure you have reviewed the guidance available on the HRA website and IRAS help before you begin your application for other approvals.

Once your application has been through Radiation Assurance you should proceed with preparing your application for any regulatory reviews your trial may need.

Applying for regulatory reviews for a combined review application involving ionising radiation

As part of your submission for regulatory reviews you’ll need to complete the ‘Ionising radiation for combined review form’ from standard IRAS. You’ll also need to include this in your combined review submission. To produce this form, and for help understanding how you can submit it, you should follow these steps.

1. Currently, combined review applications involving the use of ionising radiation also need to include information from the standard part of IRAS in their submission. To generate the required information you should create a new project in standard IRAS and complete the project filter questions.
• For filter question 2, if your application is a Clinical Trials of Investigational Medicinal Products (CTIMPs) you should select the first option; ‘Ionising Radiation for combined review of clinical trial of investigational medicinal product’. If it's an IMP/Device Trial application you should select the second option; ‘Ionising Radiation and Devices form for combined review of combined trial of an investigational medicinal product and an investigational medicinal device’

• For filter question 2e (CTIMPs) or filter question 2d (IMP/Device trials) you should select yes to the question ‘Does the study involve the use of any ionising radiation’ and enter your combined review IRAS ID. You should also ensure that you answer the subsequent question about exposure to radioactive materials.

2.Once you've completed the project filter questions, from the navigation page, you should select the ‘Ionising radiation for combined review form’. You should complete all questions that appear in the form and then obtain authorisations.

1. For studies that do not involve radioactive materials, there will only be questions enabled in Part B. Once all questions have been answered, you should obtain authorisations from the Lead Medical Physics Expert (MPE) and Lead Clinical Radiation Expert (CRE).
2. For studies that involve radioactive materials, there will be additional questions enabled in your form. The answers you give to these will also populate the preliminary research assessment (PRA) form for ARSAC. The questions you will have access to include:
   • Part A: study information (questions A1, A3-2, A4, A6-1, A6-2, A10, A11, A12, A13, A19*, A59, A60, A64-1, A71-1)
   • Part B: ionising radiation

    

   *Please note that in A19 you should include all clinical interventions/procedures to be received by participants as part of the research protocol, not just interventions/procedures related to ionising radiation. When inputting the ionising radiation interventions/procedures you should detail all research exposures, including those performed post-consent as part of standard care. If research exposures are included in A19 you should also ensure you have selected ‘yes’ in response to filter question 2b.a (‘does this study involve the use of any ionising radiation?’) in your application.

    

3. As well as obtaining authorisation from the Lead MPE and Lead CRE, you'll also need to obtain authorisation from the Sponsor's Representative.
4. Projects involving radioactive materials must also make an application to ARSAC. Applications to ARSAC should continue to follow the usual process.

3. Once you've completed all the questions that appear in the form and all relevant authorisations are in place, you should follow the instructions on the submission tab. Selecting the ‘proceed to submission’ button will not submit the form electronically. Instead, it will generate a pdf file of the form. You should then include this as a supporting document as part of your combined review submission.
4. Uploading the ‘Ionising radiation for combined review form’ into the combined review application. In the new part IRAS, you should upload the PDF file of the form to your combined review application as a supporting document. Select "Miscellaneous: non MHRA only” as the document type when uploading the file.
   
   For more general instructions on creating an application in combined review see our step-by-step user guide.

Note: The IRAS ID generated in standard IRAS is only for the purposes of generating this form. The ID generated in the new part of IRAS and associated with your combined review application should be the one used as the project identifier (this will appear as a 7-digit number).


Making changes to the ‘Ionising radiation for combined review form’

If you need to make changes to the ‘Ionising radiation for combined review form’, for example as part of a modification or Request for Further Information (RFI), you should log into standard IRAS, select the project and amend the information in the form accordingly.

Once updated, you can generate a pdf file of the form, as per the instructions above, and upload to the new IRAS system. The same applies to any changes that might be necessary for the ARSAC PRA form.


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Applications for a clinical trial of an investigational medicinal product and medical device (IMP+Device trials)

Where a proposed study is both a Clinical Trial of an Investigational Medicinal Product (CTIMP) and a Clinical Investigation (CI) of a medical device, applications must be submitted as a “IMP+Device review application” (formerly known as a Combined Devices Review Application). 

Guidance on submitting an IMP+Device review application is available on the MHRA website