Clinical Trials Latest News:
Latest Guidance and Regulatory Updates:
- updated January 2022
From January 2022 all new CTIMPs will be reviewed and approved through Combined review. This will also include medical devices.
Latest MHRA and HRA COVID-19 Updates:
Regulatory status of equipment being used to help prevent coronavirus (COVID-19) (this includes hand gels and PPE)
Managing clinical trials during the Coronavirus pandemic
Sponsor guidance for clinical trials resuming on-site monitoring:
- All on-site monitoring must conform to the social distancing and quarantine rules in force at the locality at the time
- The safety of research participants, site staff, researchers and monitorsshould be the paramount consideration in decisions about whether and how to start or re-start on-site monitoring
- If on-site monitoring involves travel, the risk and (in)convenience of travel has to be considered
- The monitor must be able to conform to site requirements for resuming on-site monitoring
- Remote monitoring should continue until the minimum expectations can be met
- The trial risk assessment should be updated to take the above points into account where relevant
- Deviations from the monitoring plan will need documenting, and any gaps in monitoring should be addressed in the risk assessment with mitigations in place
The MHRA and HRA guidance on changes to monitoring as a result of COVID should also be taken into account:
Sponsor expectations for clinical trials resuming recruitment:
Please refer to the NIHR restart framework https://www.nihr.ac.uk/documents/restart-framework/24886
The NIHR restart checklist (or adapted checklist) should be completed and for the trial to restart when ready, provided the trial risk assessment has been updated considering the risks and mitigation strategies around COVID-19 for trial staff and participants, and provided the site has given written confirmation of agreement to reopen.
Please also refer to the latest university guidance on re-starting research, at https://www.staffnet.manchester.ac.uk/rbe/ethics-integrity/ethics/
For more in-depth information regarding clinical trials, please see the relevant subsections.
Please note the Sponsor requires 10 working days to review the following documentation. This timeframe covers our initial review only and there will be a further 10 working days for each subsequent review:
- IRAS Documentation: REC/HRA
- MHRA Documentation
- Greenlight Documentation
Dr Mohammed Zubair - Research Governance, Ethics and Integrity Manager
Directorate of Research and Business Engagement
The University of Manchester
Manchester, M13 9PL
Tel: 0161 275 2725 / 0161 275 2167
The UoM require a 12 week lead time in order to consider sponsorship in principle.