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Radiation Assurance: one year on

Last updated on 23 May 2019

Our Radiation Assurance review is marking its first birthday. 

Back in April 2018, Radiation Assurance opened to receive oncology studies taking place in the NHS for review.  

Radiation Assurance clarifies the information regarding research radiation exposures in study documentation at an early stage in the research regulatory approvals pathway. It coordinates the lead Clinical Radiation Expert (CRE) and lead Medical Physics Expert (MPE) reviews in Part B section 3 of the Integrated Research Application System (IRAS) application form. It also uses standardised UK-wide guidance and generic risk statements to complete the review. 

For more information on the process and its benefits please visit our webpage.

“Since opening we have been testing how the new review process and guidance has worked in practice.  Things went so well in our first phase of roll-out that we only needed to make minor clarifications to our guidance before rolling out to our second phase in November 2018. In the second phase we started accepting cardiology, neurology and rheumatology studies in addition to oncology studies.” 

- Anoushka Tepielow, HRA Approvals Manager – Technical Assurances

Some of the highlights from the first year of Radiation Assurance include:

  • more than 50 submissions being received and processed through Radiation Assurance
  • 132 reviewers (MPEs and CREs) currently registered to support and undertake reviews, with more still going through the registration process
  • an average timeline of just 27 days for completed HRA-managed reviews, beating our target of 40 calendar days to complete the review
  • an average timeline of just 5 days for completed self-managed reviews, exceeding the target of 14 calendar days to complete the consistency review.

For HRA-managed studies the time it takes to complete the review is measured from the date on which we receive the appropriate documents to the date on which Radiation Assurance is issued. The target timeline therefore includes the consistency review, sourcing MPE and CRE reviewers, and the completion of their review, but excludes the time it takes for applicants to respond to any queries raised. 

For self-managed studies the HRA aims to complete the consistency review within a maximum of 14 calendar days of a submission being received, excluding any time it takes an applicant 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.

“Whilst it is fantastic that the timelines we have achieved are much lower than those we are advertising, we won’t be reducing the target timelines unless we can be sure that we are able to sustain them with more submissions received.  We’ll be keeping an eye on this as we receive more submissions.”

- Anoushka Tepielow, HRA Approvals Manager – Technical Assurances

Feedback from applicants and reviewers has been positive. Our case study has further information and focusses on an applicant’s perspective of how helpful Radiation Assurance is.

“This insight helped to shape the process, and highlighted ways to make it even more effective and efficient before we rolled out the second phase in November.  The feedback we have received since then will be used to optimise the process further before accepting all other study types.”

- Anoushka Tepielow, HRA Approvals Manager – Technical Assurances

We are keen to accept further studies for review to continue to test the process and guidance.  We would encourage sponsors to look at the information for applicants on our Radiation Assurance page, with submissions guidance on the IRAS website.

Additionally, we are particularly interested in continuing to recruit reviewers, specifically CREs, to review studies through Radiation Assurance.  Further information for interested MPEs and CREs is available on our recruitment page.

We are now looking forward to the roll-out of phase three later this year, where all other NHS studies involving ionising radiation will be accepted for Radiation Assurance.

We welcome your feedback on the Radiation Assurance process and the guidance we have provided. Please complete our online survey. Responses will be reviewed as part of the evaluation at the end of each phase of roll-out.

If you have any questions about Radiation Assurance, please contact us at hra.radiationassurance@nhs.net

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