Both processes have been developed with sector experts and respond directly to user feedback that gaining sign off for studies involving radiation, and sites’ understanding the pharmacy implications of studies has been proving difficult.
The purpose of this work is to bring consistency and clarity to both processes and reduce duplication, ensuring applicants gain their radiation sign off, and pharmacy departments receive the appropriate information to set the study up effectively.
The Radiation Assurance has been developed following testing through the Experimental Cancer Medicine Centres. Researchers told us there was a difficulty in identifying appropriate experts to complete the application form, and variation in the wording used to describe the risk of taking part in a study for a patient. We’ve worked in collaboration with experts across the UK to develop an approach that includes ensuring that there are suitably trained professionals available to fulfil the requirements within the Integrated Research Application System (IRAS) form.
We have developed our Pharmacy Assurance process in response to large numbers of queries around pharmacists’ reviews being sent by sites to the sponsor, as the information was not readily available at the time of site set up. In response, we’re implementing a system where technical pharmacy information is being provided within one centralised format which can be used by all participating sites. Again this has been developed collaboratively with experts around the UK.
Support to both of these areas should reduce the number of queries which sites raise and which sponsors have to deal with, and both will be supported and managed by the HRA.
A set review fee of £500 per review, per reviewer, is being introduced to assist trusts in providing these services and to help sponsors budget accordingly. This applies to both pharmacy and radiation.
In collaboration with our expert groups, we have also developed two different routes to support sponsors and sites in getting the most out of the processes:
- most studies will be processed as HRA-managed, and we will manage the review process on behalf of sponsors and reviewers
- where the sponsor and reviewing trust are the same organisation (and the reviewer conducting the review is registered with the HRA) they will be able to manage the review process themselves, though the study would still be registered with the HRA – this will be called self-managed review.
Clinical Radiation Expert (CRE) and Medical Physics Expert (MPE) Reviewers
We are pleased to announce that we will be opening our registration for Clinical Radiation Expert (CRE) and Medical Physics Expert (MPE) reviewers in the next couple of months for Radiation Assurance. Registration for pharmacy reviewers for Pharmacy Assurance will follow shortly afterwards.
Further information will be made available on our website over the coming weeks about how to register as a reviewer.
This will also be accompanied by announcements about when each assurance will roll out to accept applications under the new process, including guidance on the review processes and how to pay for them.