Help - Preparing & submitting applications - Radiation Assurance
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Radiation Assurance

Radiation Assurance





IMPORTANT: Combined Review Applications

Radiation Assurance applicants who will submit through the combined review service in the new part of IRAS should ensure they have reviewed the additional Radiation Assurance guidance available on the HRA website. We recommend that they do this before starting their combined review application.





IMPORTANT: From 01 November 2021 any study involving ionising radiation, which is taking place in NHS/HSC secondary care settings, can apply for Radiation Assurance.

 



Radiation Assurance is for studies where there are ionising radiation research exposures which are taking place in the NHS/HSC.

 

This page provides the following information:

 


What is Radiation Assurance?

 

Radiation Assurance is a process to assist you in securing the Clinical Radiation Expert (CRE) and Medical Physics Expert (MPE) reviews in Part B Section 3 of the IRAS form ready to submit it for the required regulatory approvals. It is managed by the HRA on behalf of all four UK nations. It is designed to deliver the following benefits:

  • Implementation of a Radiation Assurance consistency review prior to CRE and MPE reviews, leading to greater consistency of information regarding ionising radiation information in applications

  • Assisting you in finding CREs and MPEs with the appropriate expertise to review your study

  • Greater clarity for CRE and MPE reviewers, who review through Radiation Assurance, on which information should be presented in Part B Section 3 of the IRAS form

  • Providing generic statements about the risk of the exposure of ionising radiation to Research Ethics Committees (RECs) and the Administration of Radioactive Substances Advisory Committee (ARSAC) within the IRAS Form, and to participants in the Participant Information Sheet (PIS)

  • Providing assurance to applicants, regulatory bodies and participating sites that the information within the IRAS Form contains the required information to the set Radiation Assurance standards

  • Reducing site set up times by reducing the number of queries raised at site level, as a result of more consistent and accurate application documents

Radiation Assurance has introduced a standardised review fee for some studies. Further information is available on the Payments Framework Guidance on the HRA website.

As Radiation Assurance progresses through a phased roll-out it will become a pre-submission aspect of the IRAS Form.

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Should you apply for Radiation Assurance?

 

Radiation Assurance is a pre-submission process and occurs before your application is made for other regulatory approvals such as REC and ARSAC reviews.

If your study will involve ionising radiation exposures in the NHS/HSC, please apply for Radiation Assurance.

If your application will be submitted through combined review, please read the guidance on this web page in conjunction with the additional guidance on the HRA website before making your application to Radiation Assurance.



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How to Apply for Radiation Assurance

 

There are two review routes through Radiation Assurance – self-managed and HRA-managed. Please see the flowcharts on the HRA website for an overview of what happens in each review process. Detailed guidance on how to apply is available below.


Self-managed studies


If you have an agreement in place with all CRE and MPE reviewers needed to complete your review, and the reviewers are registered with the HRA, you can use the self-managed process. You can check whether a CRE or MPE is registered with the HRA by using our Registered Reviewer List.

In this process, the HRA will conduct a consistency review on the application, but you will manage the review process with the reviewers yourself. It is your responsibility to ensure that CREs and MPEs of the appropriate expertise are selected to conduct the review.

Further information on reviewer specialisms and implications for payment of self-managed reviews is available in the Payments Framework Guidance on the HRA website.


HRA-managed studies

Any study which cannot be self-managed will be processed as HRA-managed as long as the standard review fee is available to pay for the review. Further information on payment is available in the Payments Framework Guidance. Please note that different payment arrangements apply for any reviewers used who are based in Scotland.

Under the HRA-managed process, the HRA will conduct a consistency review on the application and assign HRA-registered reviewers to review the study. The HRA will also manage the review process with reviewers, liaising with you when required. You can request up to three trusts or health boards and, if known, reviewers at these organisations, to complete the review, though there may be instances when this cannot be accommodated. In the event that this situation arises, the HRA will contact you to discuss further options.


Submission process

Submissions for Radiation Assurance should be made before Part B Section 3 of the IRAS Form has been completed and authorised.

Supporting documents can be in draft format as long as the references to ionising radiation exposures will not be changed before the subsequent submission to the REC and ARSAC (where required).

Before you submit your application you should read the HRA’s Radiation Assurance Consistency Review Criteria, which sets out what the HRA will check the application against.

You should submit the following documents to the HRA Radiation Assurance team:

As Radiation Assurance occurs prior to regulatory approval submission, the documents should be sent by email to radiation.assurance@hra.nhs.uk with the email subject “IRAS ID xxxxxx - New submission for Radiation Assurance”. You should specify within the covering email whether you would like your submission to be HRA-managed or self-managed.

Some HRA-registered reviewers are sole traders or registered as limited companies; they do not review for a Trust/Health Board or private company. If you are submitting through the HRA-managed route and do not want the HRA to assign a study to an independent reviewer please also specify this in your covering email.

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Tips for a successful application

 

  • Make sure that you have identified and recorded all research exposures in the IRAS Form and the Research Exposure Form.

  • Sometimes protocols can be vague on requirements regarding radiation exposures, for example where it is stated that a scan will be conducted “if clinically indicated”. Even if the exposure is standard of care, it may still be considered a research exposure - make sure that you check the guidance in particular if you see wording like this in your protocol. Key things to consider include whether this is an additional exposure, whether the outcome of the exposure will affect participation in the trial, specified frequencies, and whether the results will be used to inform the planned outcomes.

  • Have a look at the Exemplar Research Exposure Forms to see how information should be recorded in the Research Exposure Form. There is one example for studies with a clear end date and a second example for studies that are open ended.

  • If there is any information requested in the Research Exposure Form which you cannot find in the study documents, it is recommended that you speak to the sponsor or chief investigator to find this information out before you submit. Examples of when you may need to do this include finding out the number of exposures which are likely to be standard of care, the radiopharmaceutical to be used for any nuclear medicine exposures, and whether biopsies or other procedures will be image-guided.

  • Ensure that the maximum number of exposures for all radiological procedures is stated in both the IRAS Form and the Research Exposure Form.

  • Make sure that all references to research exposures are consistent throughout all study documents e.g. all necessary documents state that a PET scan of the chest, abdomen and pelvis will be conducted on a six-monthly basis for two years. Double check your application before submitting it as this is a common finding in the consistency review process and can lead to longer review timelines.

  • If available, please provide a copy of the imaging manual or radiotherapy protocol at submission as this will speed up the consistency review process. Please be aware that, should either of these documents be referenced in the protocol, the HRA will request them prior to review.



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After you have submitted your application

 

Whether your study is self-managed or HRA-managed, once it is submitted it will go through the HRA’s Radiation Assurance consistency review. You can view the Radiation Assurance Consistency Review Criteria in the submission process guidance of the How to Apply section.

The HRA aims to complete this consistency review within a maximum of 14 calendar days of a submission being received, excluding any time it takes you to respond to queries. The HRA needs this amount of time to fully check the study against the HRA Radiation Assurance Consistency Review Criteria, and in particular to ensure that all research exposures have been identified and are consistent throughout the application – this makes it easier for the CREs and MPEs to do their reviews and provides assurance to RECs and sites on the consistency of information.


Self-managed studies

When a consistency review has been conducted and completed for your application, you will receive an email from the HRA confirming this and also that it has been registered for self-managed review. You should send this email together with the documents checked in the consistency review to the MPE and CRE reviewers who were listed in the Self-Managed Study Registration Form so that they can complete the review in part 2 and part 3 of the research exposure form respectively. It is your responsibility to liaise with the reviewers and ensure that the review is completed. There are no timelines set by the HRA for this part of the process.

Once the review is completed, you should ensure that the full Research Exposure Form is sent back to the HRA at radiation.assurance@hra.nhs.uk. This is so that the HRA can confirm by email that Radiation Assurance has been secured. Please note, Radiation Assurance will not be provided until the HRA is in receipt of the completed review.


HRA-managed studies

When a consistency review has been conducted and completed for your application, you will receive an email from the HRA confirming this. The HRA will then assign CRE and MPE reviewers to the study to conduct the review.

Where the HRA-Managed Study Reviewing Trust/Health Board Request Form is not submitted, the HRA will choose the first available reviewers of the appropriate specialisms from its list.

Where the HRA-Managed Study Reviewing Trust/Health Board Request Form is submitted, the HRA will assign reviewers from the requested organisation(s) wherever possible. If reviewers at the organisation(s) are not available, you will have the option to wait for them to become available or the HRA will choose the first available reviewers of the appropriate specialisms from its list. If you wait for reviewers to become available you should be aware that this will not count towards the HRA’s review timeline.

Please note that reviewers have the option to refuse to conduct a review (e.g. because they are about to go on annual leave). Where this occurs the HRA will then select the next available reviewer of the appropriate specialism from its list.

The HRA will provide reviewers who accept the review with a copy of the study documents and the research exposure form. If the reviewers have any queries about the information in the application, the HRA will liaise with you on their behalf to resolve the issue(s). The HRA will also give the reviewers your contact details so that they can contact you directly to begin payment arrangements whilst the review is ongoing.

Once the review is completed the HRA will send the completed Research Exposure Form back to you and confirm by email that Radiation Assurance has been secured. The HRA is currently aiming to send you this email within 40 calendar days of the initial submission being made, excluding the time it takes for you to respond to any queries raised. Please note that this timeline includes the consistency review, assigning MPE and CRE reviewers, and the completion of the MPE and CRE reviews.



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After Radiation Assurance

 

The email confirming that Radiation Assurance has been secured will include further information about what to do at this point, such as:

  • Copy the MPE and CRE reviews from the research exposure form into IRAS Part B Section 3;

  • Make any changes the reviewers have requested to be made to the Participant Information Sheet;

  • Seek authorisations from the lead MPE and CRE;

  • Make payment to the reviewing trust(s)/health board(s). The Payments Framework Guidance recommends that payment is made within 30 days of Radiation Assurance being issued, in line with NHS standard payment terms;

  • Include this email in the submission to ARSAC (where required), and in the local information pack to participating sites.

If the research exposures change after Radiation Assurance has been secured this may result in a change in the information in Part B Section 3. If this is the case, the Radiation Assurance will not be valid. A change (pre-REC favourable opinion) or substantial amendment (post-REC favourable opinion) request should be submitted to Radiation Assurance prior to submission to the appropriate regulatory bodies.

Further information on which changes to the research exposures would lead to a new submission being made to Radiation Assurance can be found in the Maintaining Your Approvals section of the IRAS Help pages, together with guidance about how to submit.

 

Providing feedback

 

We welcome all feedback on the Radiation Assurance process, including from RECs and sites who have received an application which has been through Radiation Assurance. Please contact us at radiation.assurance@hra.nhs.uk to provide feedback.

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Page last updated: 04 January 2022



 
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