This guidance is only for use by applicants who are submitting through the combined review process and who also intend their application to be processed through Pharmacy and/or Radiation Assurance. Application requirements for Technical Assurance combined review applications differ slightly due to the introduction of the new part of IRAS in March 2020. This guidance is in place as an interim solution until an Ionising Radiation and Pharmacy Assurance module is developed and released in the new part of IRAS.
Pharmacy Assurance
The submissions guidance for applications to Pharmacy Assurance is available on the standard part of IRAS.
Radiation Assurance
Documents required for combined review submissions
When you're preparing a Radiation Assurance submission the documents you need to submit depend on whether your combined review application will involve the administration of radioactive substances. The following table provides information on which documents you’ll need to submit to radiation assurance.
| Documents | Combined review applications without nuclear medicine | Combined review applications with nuclear medicine |
| Protocol | Yes | Yes |
| Any participant information sheets and consent/assent forms (with a section of text relating to ionising radiation risk) | Yes | Yes |
| Standard IRAS Form with filter page, A13 and A19 completed | No | Yes |
| New IRAS Form with B2, B4, F1 and F2 completed | Yes | Yes |
|
Research Exposure Form (with section F1 completed) This document is available on IRAS Help at https://www.myresearchproject.org.uk/help/hlpradiationassurance.aspx#How-to-Apply |
Yes | Yes |
| Imaging Manual (if available) | Yes | Yes |
| Radiotherapy Manual (if applicable to modalities included) | Yes | Yes |
|
‘Self-managed Study Registration Form’ or the ‘HRA-Managed Study - Reviewing Trust/Health Board Request Form’ (depending on which route you submit your application by) These documents are available on IRAS Help at https://www.myresearchproject.org.uk/help/hlpradiationassurance.aspx#How-to-Apply |
Yes | Yes |
You only need to have completed sections in the new part of IRAS relating to radiation exposure in order to submit to Radiation Assurance. We need this to ensure that the information on radiation exposures that you will provide to the REC is consistent with your other study documents. Information unrelated to radiation exposures is not needed for you to apply to Radiation Assurance. You can add this information in the background whilst the Radiation Assurance process is ongoing.
If your study involves nuclear medicine, you should complete the research exposure form as usual, though on page one you should specify both the IRAS ID from the new part of IRAS and the IRAS ID from the standard part of IRAS (this relates to the completion of Part B Section 3). This information is needed by the Administration of Radioactive Substances Advisory Committee (ARSAC).
Study documents do not need to be final versions but references to, and details regarding, the radiation exposures should be finalised so that no changes or amendments are required.
If you’re submitting through the HRA-managed route and wish to request either particular HRA-registered reviewers or trusts/health boards to complete the review, you should also submit the HRA-managed Reviewing Trust/Health Board Request Form detailing up to three HRA-registered reviewers or trusts/health boards.
If you’re submitting through the self-managed route, you should submit the self-managed Study Registration Form. Reviewers should be registered to review on behalf of the HRA, and you should ensure that your selected reviewers can cover all the modalities and specialisms that your study involves.
Templates for documents to be submitted to Radiation Assurance
You can find templates for several of the documents you need to submit to Radiation Assurance on the help page on the standard part of IRAS. On the IRAS help page you’ll also find the Radiation Assurance Consistency Review guidance document, which gives you tips for ensuring a successful submission to Radiation Assurance.
Submitting for Radiation Assurance
Once you’ve completed and collated all necessary documents you can submit them via email to the Radiation Assurance inbox (radiation.assurance@hra.nhs.uk). In your submission covering email to Radiation Assurance you should provide:
- confirmation that you intend to submit your study through combined review
- the latest date on which you intend to submit through combined review if this is known (this will be the last day of the submission period for the REC meeting which you intend to submit to)
- the name of the sponsor organisation, and whether they are commercial or non-commercial
- confirmation of which UK nation the lead NHS/HSC R&D office is in and, if known at the point of submission, the name of the lead NHS/HSC R&D office
- confirmation of whether the study involves adults lacking capacity
Additional document requirements for studies involving radioactive substances
If your study involves the administration of radioactive substances, you’ll also need to submit to the Administration of Radioactive Substances Advisory Committee (ARSAC) for preliminary research assessment (PRA) approval. This is only possible by using the standard part of IRAS. In this instance you should also submit a draft PDF copy of the Ionising Radiation for combined review Form from standard IRAS with the following questions completed:
- project filter page question 2 (in particular the questions about ionising radiation exposure)
- question A13
- question A19
We need the draft PDF to ensure that the information that is sent to ARSAC is consistent with the information in the rest of the application.
You do not need to do anything in Part B Section 3 as the reviewers will provide the information for you to include once Radiation Assurance has been issued. We only need the information pertaining to the radiation exposures to be provided in the PDF, so you can work on providing the other information in the background as needed for the ARSAC PRA submission.
Consistency review
Once you submit your application for Radiation Assurance the HRA will conduct a consistency review.
For information on the consistency review you should refer to the Radiation Assurance consistency review guidance document available under the “submission process” sub-heading on the Radiation Assurance page on IRAS. This gives further guidance on what the consistency review involves and what you should check to make sure your submission passes the consistency review.
We also recommend that you take into consideration the points in the 'tips for a successful application' section as these are still relevant for combined review applicants.