IRAS Development Questions and Answers
- COMBINED REVIEW: Are there any changes for ongoing CTIMP studies that didn’t go through combined review?
- I have a CTIMP application still in progress in the standard part of IRAS. What do I do?
- I have not used combined review and am getting ready to start a new CTIMP / combined IMP and device application. What should I do?
- How do I make amendments to CTIMP studies approved in the standard part of IRAS?
- What does the work to link IRAS with other research systems mean for me?
COMBINED REVIEW: Are there any changes for ongoing CTIMP studies that didn’t go through combined review?
No. There is no change for CTIMPs that you applied for using the older system, and you should continue to submit amendments and reports for these studies in the usual way.
We’ll provide sponsors and applicants with full instructions and plenty of notice for any planned changes in the future, such as the migration of existing, ongoing studies.
I have a CTIMP application still in progress in the standard part of IRAS. What do I do?
If you have not already done so, please contact the combined review team immediately for advice and support at cwow@hra.nhs.uk.
I have not used combined review and am getting ready to start a new CTIMP / combined IMP and device application. What should I do?
CTIMP applicants and sponsors new to combined review should visit our dedicated webpages to get started in the new system.
Remember, it is no longer possible to start a new CTIMP application in the standard part of IRAS.
For all other study types, please continue to use the standard part of IRAS in the usual way.
How do I make amendments to CTIMP studies approved in the standard part of IRAS?
Amendments should continue to be made using the amendment tool and the standard amendment processes. The amendment tool generates the same information as Annex 2 and is accepted by the MHRA. You can find out more in IRAS Help. Amendments for combined review studies are submitted via the new part of IRAS.
What does the work to link IRAS with other research systems mean for me?
When you create a project in IRAS it’s given a unique IRAS ID. Research organisations across the UK will use the IRAS ID as a common identifier, ensuring your project can be tracked from funding through to delivery and dissemination.
Your IRAS ID will be used by everyone involved in the project, whatever the type of health and social care research and the approvals required. Even if you do not need to use IRAS to make an application for approvals, say if your study is not taking place in the NHS and does not require review by the UK Research Ethics Service, you will still go into IRAS to generate your IRAS ID so there is clear visibility and oversight of all UK studies.
Your IRAS ID will help you access support services via the UK Central Portfolio Management System (CPMS). This includes the online Schedule of Events Cost Attribution Template (SoECAT) for non-commercial funding applications and the interactive costing tool (iCT) for commercial projects, enabling speedy UK study set-up. Some research funders may also ask for your IRAS ID when you apply to them.
Find out more and get your IRAS ID at IRAS Help.