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 should contact cwow@hra.nhs.uk. All existing projects must be submitted by 28 February 2022.

If you are about to start a new CTIMP application, please refer to the guidance on the HRA website about how to apply for combined review. All combined review applications are prepared in the new part of IRAS. If your combined review application involves ionising radiation and/or an investigational medical device, please refer to IRAS Help guidance.


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.

IMPORTANT: Advance notice of essential maintenance work scheduled for Wednesday 19 January – information for users about expected system availability.
IRAS will not be available to users from 19.00 to 23.00 GMT on Wednesday 19 January 2022 while essential system maintenance work is carried out.

Updates:

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.

25 May 2021: IRAS updated to v5.20 This version includes updates to the MHRA Devices application to reflect the implementation of the EU Medical Devices Regulation in Northern Ireland. It includes changes to enabling of the form, questions, questions specific guidance and declarations / electronic authorisations. 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
• 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