Announcements:

Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials):
It is no longer possible for a new CTIMP or IMP/Device trial application to be made using this part of IRAS. If you have an existing CTIMP or IMP/Device trial project that has not yet been submitted, you will no longer be able to do so here.

All CTIMPs and IMP/Device trials now need to apply using the combined review service, which can be accessed using the new part of IRAS. Please refer to the guidance on the HRA website for instructions on how to apply for combined review. If you have any queries related to applying for combined review please contact cwow@hra.nhs.uk. If your combined review application involves ionising radiation and/or an investigational medical device, please refer to IRAS Help guidance.


Expiration of the Control of Patient Information (COPI) Notice:
If you are relying on the General COPI Notice and need to process confidential patient information for COVID-19 purposes after 30 June 2022 you need to establish an alternative lawful basis. Some alternatives will require an application to CAG, which must be submitted no later than 8 weeks before the COPI Notice expires. For more information refer to the HRA website.


Radiation Assurance:
From 1 November 2021 any study involving ionising radiation, which is taking place in NHS/HSC secondary care settings, can apply for Radiation Assurance.


Coronavirus / COVID-19 - key guidance for sponsors, sites and researchers:
The Health Research Authority (HRA) website provides guidance about Research Ethics Committees (REC) and NHS/HSC arrangements and information about fast track review of COVID-19 research. For guidance relating to clinical trials of investigational medicinal products (CTIMPs) and medical devices please refer to the Medicines and Healthcare products Regulatory Agency (MHRA) website.

Updates:

28 February 2022: IRAS updated to v6.2 This version implements further updates to Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials) projects that were created before IRAS v6.0 (13 December 2021). Please refer to the Updates page for more information.

04 January 2022: IRAS updated to v6.1 This version implements updates to Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials) projects that were created before IRAS v6.0 (13 December 2021). Please refer to the Updates page for more information.

13 December 2021: IRAS updated to v6.0 This version removes the option in the project filter to create new Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials). A new “Ionising radiation for combined review form” is introduced to support the radiation elements of combined review studies. Please refer to the Updates page for more information.

• Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
• Generates the IRAS ID, which has been adopted by stakeholders across the UK as the common study identifier
• Enables you to enter the information about your project once instead of duplicating information in separate application forms
• Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
• Helps you to meet regulatory and governance requirements

• Administration of Radioactive Substances Advisory Committee (ARSAC)
• Confidentiality Advisory Group (CAG)
• Gene Therapy Advisory Committee (GTAC)
• Health Research Authority (HRA) and Health and Care Research Wales (HCRW) for projects seeking HRA & HCRW Approval
• Medicines and Healthcare products Regulatory Agency (MHRA)
• NHS / HSC R&D offices
• NHS / HSC Research Ethics Committees
• Her Majesty's Prison and Probation Service (HMPPS)
  
• Social Care Research Ethics Committee