Clinical Trials
Sponsorship, oversight, and insurance for UoM clinical trials.
Important Notice
From 28 April 2026, new UK regulations for Clinical Trials of Investigational Medicinal Products (CTIMPs) will come into force (The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025/538), alongside the updated Good Clinical Practice (GCP) standard, ICH E6(R3). These changes are intended to modernise, streamline and strengthen the conduct and oversight of clinical trials in the UK.
As a result, all sponsors, Chief Investigators and research teams involved in CTIMPs will be required to ensure that their trials are conducted in compliance with the new regulatory framework and updated GCP principles from this date.
The Clinical Trials Sponsorship Office at The University of Manchester is currently reviewing and updating relevant SOPs, templates and guidance documents to align with the new requirements. Further information and updated documentation will be published in due course.
If you have any questions about what these changes mean for your trial or upcoming applications, please contact us at clinicaltrials@manchester.ac.uk. We are here to support you through the transition.
The Clinical Trials Team at the University of Manchester is responsible for providing sponsorship of clinical trials led by chief investigators (CIs) who are UoM employees, especially those that involve the testing of a medicine or a medical device. This type of research is highly regulated and must adhere to UK law and international good standards. In line with these requirements, the sponsor assumes legal responsibility for such trials and provides insurance, which is a mandatory requirement for all clinical trials.
It is important to note that sponsorship differs from funding. While the sponsor handles legal aspects and insurance, the funder provides the financial resources needed to conduct the trial. Although the university occasionally funds trials, this funding does not come through the Clinical Trials Team. For more information on funding through university, please refer to the Funding Support for Researchers.
If you are interested in knowing more about clinical trials and how the team can help you, then please read the information provided to better understand the policies, processes and guidance on offer.
Review timeframe
The Clinical Trials Team works to different timelines.
Sponsorship in principle: Allow a 12-week lead time at the funding application stage (longer if the trial involves a CTU or contract manufacturer).
Post-funding reviews: 10 working days for an initial review, and up to 10 working days for each subsequent review (e.g. IRAS documentation [REC/HRA], MHRA documentation, amendments, Greenlight documentation).
Contact Details
Dr Mohammed Zubair - Research Governance, Ethics and Integrity Manager
Directorate of Research and Business Engagement, Christie Building, The University of Manchester, Manchester, M13 9PL
Email: mohammed.zubair@manchester.ac.uk
Tel: 0161 275 2725
For CTIMP queries, including ATMPs email us at clinicaltrials@manchester.ac.uk.
For medical device queries, including AI queries email us at medicaldevices@manchester.ac.uk.
For reporting urgent issues related to sponsored trials email us at saereporting@manchester.ac.uk.