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Radiation Assurance

 

What is it?

The HRA Radiation Assurance process clarifies the information regarding radiation exposures in study documentation at an early stage in the research regulatory approvals pathway. It also coordinates the Lead Clinical Radiation Expert (CRE) and Lead Medical Physics Expert (MPE) reviews required in the Integrated Research Application System (IRAS) application form.

Radiation Assurance will be a component of HRA Approval once a phased implementation is completed. Until then, Radiation Assurance will remain a separate process.

 

What studies are currently accepted?

The HRA is currently accepting studies meeting all the following criteria for review through the Radiation Assurance process:

  • Clinical trials, categorised as the first four options in question 2 of the filter page of the IRAS form, involving ionising radiation;
  • The disease being studied is cancer;
  • The lead site is part of the Experimental Cancer Medicine Centre network.

 

If your study meets these criteria and the Lead CRE and MPE reviews have not already started, you should complete Part F1 of the Research Exposure Form which is available in our Documents section. Please then email the Technical Assurances Officers at hra.radiationassurance@nhs.net to submit your application for review.

 

How does the process work?

When a study is submitted for Radiation Assurance, the Technical Assurances Officers will check that they have all of the documents they need in order to validate the application. These are:

  • Protocol;
  • IRAS form;
  • All Participant Information Sheet(s) and Consent Form(s);
  • Research Exposure Form with Part F1 completed;
  • Imaging Manual (if applicable);
  • Radiotherapy Manual (if applicable).

We will only validate the application when we have received all of the above documents. Our validation criteria can be found in the Documents section.

of this page.

There is a flow chart of the review process which is also in our Documents section.

 

What are the benefits of the process?

Radiation Assurance is designed to deliver the following benefits:

  • Early identification of inconsistencies and lack of clarity in research applications.
  • Giving greater clarity regarding the information requirements to enable both the IRAS authorisations and site set up to go ahead.
  • Supporting applicants by identifying the experts with the correct specialist knowledge to be able to conduct the assurances.
  • Providing assurance to applicants, sites and Research Ethics Committees (RECs) that the information provided in the IRAS authorisation contains all of the required information to a set standard.
  • Reducing site set up times by reducing the number of queries which need to be raised due to a higher quality of information.
  • Implementing a standard research cost for the completion of authorisations within a new payment framework, making it easier for sponsors to request the correct amount of funding.

 

Is there a charge for review?

Some Reviewers may require payment in line with their Trust’s standard procedures but this will be discussed with the sponsor before a review is initiated. The amount that the review will cost is at the discretion of each Trust. Payment on completion of the review should be managed directly between the sponsor and the Reviewers.  Please note that in future there will be a standard charge for conducting a review – see ‘Is there a payment involved?’ 

Coming soon

  • Publication of our Payments Frameworks Guidance for funders, sponsors and sites.
  • Securing continuing CRE and MPE involvement for ongoing developments and improvements to the process
  • Recruitment of additional CRE and MPE Reviewers.
  • Opening to other study types – the next studies to be accepted will be all oncology studies involving ionising radiation.

 

Documents

Frequently Asked Questions

HRA Radiation Assurance Evaluation

Research Exposure Form

Review Process Flow Chart

Validation Criteria

 

Contact details

Contact us at hra.radiationassurance@nhs.net