The Clinical Trials Team at the University of Manchester provides sponsorship for clinical trials when the chief investigator (CI) who runs them is an employee of UoM. A sponsor takes legal responsibility for trials and provides insurance. All clinical trials require a sponsor. Sponsorship is distinct from funding. The funder gives you money to pay to run your trial. UoM occasionally funds trials, but this does not come through the Clinical Trials team. Please see Funding Support for Researchers for further information on funding through UoM.
Clinical Trials News:
- Updated June 2022
Clinical trial law has changed since Britain left the EU. With the Medicines and Medical Devices Act 2021, the UK has altered the existing regulations to create more efficient and transparent clinical trials. Many of the alterations aim to more closely mimic the way clinical trials have been conducted during the COVID-19 pandemic, where rapid approvals and open access have been essential.
As part of this new act, from January 2022, all new CTIMPs and medical devices will be reviewed and approved through a Combined IRAS Review.
The Medical Device Summer Compliance Survey is also now live.
Latest guidance on changes to Clinical Trial processes post-Brexit
MHRA guidance on changes to regulation of medical devices from 1st January 2021
Where remote monitoring is still in place
For more in-depth information regarding clinical trials, please see the relevant subsections in the menu of the left-hand side.
For information on COVID, please refer to these links:
MHRA Building resilience into clinical trial design and conduct during the pandemic
HRA COVID-19 guidance for Researchers
MHRA Managing clinical trials during Coronavirus
Process for developing new assays for COVID-19 and applying for funding
Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
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.