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Clinical Trials

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, work to different timelines.

There is usually a 12 week lead time to consider sponsorship in principle at the funding application stage.  In some instances this may be longer, especially, if the trial involves a CTU and contract manufacturer.

Following confirmation of funding, the team will require 10 working days for an initial review only and there maybe a further 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