Researchers take advantage of new systems for study applications

Meanwhile our new online booking service has also been well received by researchers since its launch on 19 May. Applicants are taking advantage of being able to book and submit applications 24 hours a day – with 30 percent using the system outside office hours.

We are delighted that the additional flexibility and ease of use of these online services have been adopted so readily.

The new systems are part of our ongoing programme to improve services for research approval applicants.

The online booking service offers access to study review at the click of a button. Applicants can now choose a date for their study to be reviewed by a Research Ethics Committee (REC) and make a booking anytime, rather than having to telephone during office hours. And with all RECs taking place via video conference, they can discuss the study with the REC without having to travel.

We’re not offering this service to applicants for review of COVID-19 studies. These studies are still being handled through our fast-track service – please contact us via fast.track@hra.nhs.uk and we will handle the booking for you.

The online amendments service offers tailored advice to applicants about how to get their amendment approved, based on the changes that are being made to their study. A new tool categorises each amendment and provides tailored guidance on submission, including which review bodies the amendment needs to be sent to.

Applicants can then submit their amendment documentation online – via a new part of the IRAS (Integrated Research Applicant System) website – removing the need to email them. This makes it easier for applicants to track the submission history of their amendments.

All applicants making an amendment to project-based research now need to complete submit their amendment online and use the new the amendment tool. The tool replaces the Substantial Amendment Notification Form, and Non-Substantial Amendment forms and clarifies which amendments do not need to be submitted for review. For amendment to clinical trials of investigational medicinal products (CTIMPs), the EudraCT Annex 2 amendment form will still be required and can be completed within the tool. Sponsors will no longer receive a categorisation email post-submission, and instead will receive an automated acknowledgement email confirming the submission has been successfully received. The amendment tool outputs include the category of the amendment, which should be shared with sites directly by the sponsor after the amendment has been submitted, if submission is required. Amendments to Research Tissue Banks and Research Databases also now need to be submitted online, but do not need the amendment tool.