The HRA are pleased to inform you about updates being made to the combined review system for Clinical Trials of Investigational Medicinal Products (CTIMPs) in the next few days. These new updates mean that sponsors and applicants using the system will now be able to manage the end-to-end lifecycle of the combined review through IRAS – from application through to amendment, safety reporting, end of trial notification and submission of summary results.
They also have details of what to do if you are yet to submit a CTIMP application via combined review, and how to make sure you’re ready for 1 January 2022 when it will become the only way to apply.
What are the new system improvements?
Where a USM relates to an application approved via combined review, applicants will be able to submit USM notifications (along with supporting documents) to the MHRA via IRAS, rather than submitting the notification via email. If the USM also relates to other ongoing trials, applicants will only need to submit one notification via IRAS, including details of the other affected trials. This avoids the need to submit multiple notifications for the same USM.
Users will note that new document categories have been created in IRAS for document types which may be needed in USM submissions – Dear Investigator Letter and Safety Review Report. Once USMs have been received, the MHRA will be able to request any points of clarification via IRAS and applicants will be able to respond directly and upload any additional documents required.
The outcome of the USM will be issued by the MHRA via email and the outcome will also be available to view on the IRAS dashboard. For USMs that are accepted, applicants will then be able to submit a substantial amendment, identifying that the amendment is linked to an agreed USM.
Applicants will be able to notify the MHRA and REC of the end of a trial through IRAS, for both UK and Global EOT submissions.
Applicants will be able to submit:
• UK and Global EOT date - MHRA and REC
• Early termination - MHRA and REC
• Clinical summary results – MHRA only
There will also be functionality for the MHRA to request any points of clarification and for applicants to respond directly in IRAS.
• Functionality has been added to provide the sponsor amendment reference number and sponsor amendment date. This will populate directly into letters issued by the regulators and will ensure that it is the sponsor allocated amendment number which appears on these documents.
• Applicants will no longer need to select which regulators to submit a substantial amendment to. The appropriate regulatory review will be determined by the type of document that is being submitted with the substantial amendment.
• There is also now functionality to submit non-substantial amendments (HRA and HCRW Approval / NHS/HSC R&D permissions) via IRAS.
The MHRA validation/acknowledgement letter will be available on the applicant’s IRAS project dashboard when their initial submission has been received (in addition to receiving an email). This applies both to initial applications and substantial amendments.
Applicants will be able to respond to requests for points of clarifications and provide updated or additional documents requested by the REC as part of the Request for Further Information (RFI) process. Previously it was only possible to make one RFI response submission, which meant that any documents that were not included within this submission would not be visible as approved documents on the IRAS dashboard. This improved functionality will mean that all of the approved documents will show on the IRAS dashboard when the application is approved.
More detail about these changes will be published in our step by step guidance document after the functionality goes live.
To read more see the HRA website.