IRAS
Trial Approvals Phase
The IRAS station follows the Final Protocol station and CI Checklist Before Seeking Approval, and precedes the CTA Submission station. Applying to IRAS is good practice and is relevant to all trials. This station is part of the 'trial approvals phase' group of stations.
IRAS
The Integrated Research Application System (IRAS) is a single online system used to apply for the permissions and approvals required for health, social, and community care research in the UK. IRAS streamlines the approvals process by allowing applicants to enter project information once for use in applications to multiple approval bodies, such as the Medicines and Healthcare Products Regulatory Agency (MHRA), the Health Research Authority (HRA), Research Ethics Committees (RECs) and Research and Development offices.
IRAS can be used by anyone conducting health and social care research, including Chief Investigators and those delegated responsibly for preparing and submitting research permissions and approvals. In addition to new study applications, IRAS is used to create and submit notifications, such as a 'Notice of Substantial Modification' (see Modifications station).
For non-commercial studies, IRAS supports a consistent UK-wide approach to study set-up and delivery. The Organisational Information Document (OID) in outline format forms part of the IRAS submission. A localised version of the OID forms part of the UK Local Information Pack, which is required for both commercial and non-commercial research.
Clinical Trials of Investigational Medicinal Products (CTIMPs) and IMP/Device trials must apply through the Combined Review, accessible via the new part of IRAS. Users must create a new IRAS account to use this system. Step-by-step guidance on how to apply for a combined review is available on the HRA website. The MHRA provide specific guidance (.PDF) and instructions on IMP/Device trials.
Non-CTIMPs
Non-CTIMPs continue to use the standard IRAS application pathway (not the combined review system).
Further Reading
- IRAS Guidance: Combined review applications involving ionising radiation.
- CTA Submission station.
- Ethics Submission station.
- R&D Submission station.