INDUSTRY COMMENTARY:
Insight from Karin van Dort, Product Owner, psiXchange
The Integrated Research Application System (IRAS) is a single system for applying for the permissions and approvals for health, social and community care research in the UK.
Research applicants are able to submit research applications to the Health Research Authority through IRAS, including those for HRA Approval, applications for Research Ethics Committee (REC) review, as well as applications for the Confidentiality Advisory Group (CAG).
The IRAS system now has a new feature for combined review, which has implications for submitting Drug Safety Update Reports (DSURs) and Urgent Safety Measures. The HRA has published a step-by-step guide to using IRAS for combined review, which you can access here.
As of 1 January 2022, combined review is the way all applications for new Clinical Trials of Investigational Medicinal Products (CTIMPs) and combined IMP/device trials must be made.
Key changes to Development Safety Update Reports (DSUR)
DSURs can be submitted within IRAS. It is also possible to continue to submit DSURs via the Human Medicines Portal where necessary (for example, where different organisations have oversight of the reporting functions). You should either submit DSURs for a project in IRAS or on the Human Medicines Portal, not both.
DSURs do not need to be reported separately to the REC.
Key changes to Urgent Safety Measures (USM)
Notification of Urgent Safety Measures can be submitted to the MHRA via IRAS, rather than submitting the notification via email.
The process for completing an USM notification, including bulk upload if required, is the same as for DSURs. The outcome of the USM will be issued by the MHRA via email and the outcome will also be available to view in IRAS. 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.
USMs do not need to be reported separately to the REC.
Proposed changes to Safety reporting
For clinical trials, the HRA is proposing to remove the requirement for individual Suspected Unexpected Serious Adverse Reactions (SUSARs) to also be reported to all investigators, to reduce the burden on sponsors and investigators without impacting on participant safety. The HRA proposes that informing Investigators of safety information is better met via the Investigator’s Brochure (a comprehensive summary of clinical and non-clinical data about the medicinal product compiled throughout the study), which is updated at least annually.
The HRA is also proposing to remove the requirement to report SUSARs and annual safety reports to RECs, foreseeing that the MHRA will lead on assessment of these and liaise with RECs as necessary. These proposals are to remove duplicative reporting requirements and would not reduce oversight of participant safety. Currently each SUSAR needs to be reported to the MHRA in an expedited manner. The HRA is proposing that SUSARs can be reported in an aggregate manner, provided that the trial protocol mandates continuous monitoring of serious adverse events/reactions, plus remove the requirement to include listings of serious adverse events and serious adverse reactions in annual safety reports (Development Safety Update Reports). The reports should instead include an appropriate discussion of signals/risks associated with the use of the medicinal product as well as proposed mitigation actions.
Finally, when an investigator or Sponsor takes an appropriate Urgent Safety Measure during a trial to protect participants from an immediate safety risk, they are currently expected to notify the regulator as soon as possible (this is usually via a phone call within 24 hours of the measure being taken) and also provide written notice to the MHRA, currently within 3 days. The HRA proposes to extend this written notification from no later than 3 days from when the measure was taken, to no later than 7 days to promote international harmonisation of reporting windows.
This open consultation for changing the regulations for clinical trials is available for responses now and can be found on the UK government website: Proposals for legislative changes for clinical trials – GOV.UK (www.gov.uk)
