Radiation Assurance is for all studies involving ionising radiation which are taking place in NHS/HSC secondary care settings.
How does the process work?
Radiation Assurance is a pre-submission review. This means it takes place before e-submission of the IRAS Form and before an application is made to the Administration of Radioactive Substances Advisory Committee (ARSAC).
Once we've received your study application, we will conduct a consistency review, which ensures that regulators and sites receive consistent information across an application.
You should make sure you include all of the required documents.
For guidance on which documents you need to submit for Radiation Assurance, the criteria for the consistency review and tips on making sure your application passes the consistency review, see our Radiation Assurance page on the IRAS website.
If you plan to submit your application via the combined review process, separate guidance is available.
You'll also need to tell us which management route you would like your study to be processed through. This means either the HRA managed or self-managed route.
Once we've completed our consistency review to ensure all research exposures have been identified and are referenced consistently across study documents, the study can be sent for review by the Medical Physics Expert(s) (MPEs) and Clinical Radiation Expert(s) (CREs).
There are two management routes for Radiation Assurance:
HRA-managed
The HRA manages this process on behalf of the applicant. Applicants using this route will need to pay a review fee to the reviewing trusts, organisations or independent reviewers. You should be aware that if a study involves multiple modalities, for example radiology and radiotherapy, it may be necessary to select more than one MPE and CRE reviewer to complete the review, which can impact on the cost of the review fees payable. For further details on review fees and nation variability, you should read our Payments Framework Guidance.
If you submit your study through the HRA-managed route, you have the choice to request up to three trusts, health boards or individual reviewers for the HRA to approach to undertake the review. Alternatively, we will select appropriate HRA-registered reviewers with the appropriate expertise in the clinical specialisms and modalities required by the study.
This flow chart shows the process for the HRA-managed route.
Self-managed
If you submit a study through the self-managed route you will manage the selection of reviewers and the review process. Reviewers you select to undertake the review should meet the following criteria:
- be registered with the HRA - please see our list of currently registered reviewers
- have appropriate experience in the clinical specialisms and imaging modalities required by the study.
You're expected to have a contract in place with your chosen reviewers when you submit your application for self-managed review. We recommend that this includes timelines and the agreed fee for completion of the review. There is further information on fees in our Payments Framework Guidance.
You should specify which reviewers have been selected when registering your application for self-managed review. If you have reviewers that you would prefer to use who are not currently registered with us, you should encourage them to register with the HRA. More information is available on our reviewer registration page.
As part of this route, you'll still submit all of your study documentation for registration and have a consistency review conducted by the HRA.
This flow chart shows the process for the self-managed process.
What are the timelines for review?
We are currently testing a timeline for HRA-managed studies of a maximum of 40 calendar days (excluding queries). For self-managed studies we aim to complete the consistency review within a maximum of 14 calendar days (excluding queries). As the rest of the process is managed by the applicant, we do not provide a timeline for this. You can see the timelines we are currently achieving on our main Radiation Assurance page. As we collect more data about the actual time taken for Radiation Assurance, timelines may adjust.
Feedback from both commercial and non-commercial sponsors has shown that they have benefited from a reduction in queries around consistency of radiation information and dose and risk calculations during the review process. They also report fewer queries at sites about the practical arrangements relating to radiation set-up, leading to quicker set-up times.
Still got questions?
Visit our FAQs page.