From Wednesday 30 September 2020, the HRA Radiation Assurance process (all nations) now:
- accepts all studies involving general radiology
- allows HRA registered reviewers (MPEs and CREs) to register to undertake reviews independently (as well as through their employer) if they choose to
- enabling commercial sponsors to use their choice of Radiation Reviewers and their agreed timelines through the self-managed route
This means you can now benefit from Radiation Assurance for all studies involving general radiology, as well as all radiation modalities for oncology, cardiology, rheumatology and neurology. Further guidance on what constitutes general radiology will be available on our website from next week.
The opening of the self-managed process allows commercial sponsors to work with reviewers that they already have existing relationships and contracts with, as well as maintain control over their own review timelines. This can be particularly beneficial to sponsors opting to submit their studies through the Combined Ways of Working (CWoW) pilot.
Studies still need to be submitted to the HRA for registration and a full consistency review to take place. This makes sure that Research Ethics Committees and sites do not waste time clarifying inconsistent information across the application. Once this has been completed, the review process is then managed by the commercial sponsor. The completed Research Exposure Form will need to be returned to the HRA for Radiation Assurance to be confirmed so that HRA Approval or study-wide review can be completed.
Commercial sponsors who want to use this service are encouraged to check that their regular reviewers are registered to review studies on behalf of Radiation Assurance. If reviewers are not currently registered, we strongly encourage them to apply to become HRA registered reviewers at the earliest possible opportunity. Commercial sponsors who use Radiation Assurance benefit from a reduction in queries around consistency of radiation information during the approval process, and avoid problems at sites about the practical arrangements relating to radiology set-up.
If you have any specific questions relating to Radiation Assurance process, please email Radiation.email@example.com.