Clinical Research Compliance Team (CRCT)
The Clinical Research Compliance Team (CRCT) helps to ensure clinical research projects are conducted in line with any applicable regulations, international standards and University policies. All clinical research must be conducted in accordance to the University's Clinical Research Quality Management System (QMS).
- Due to the Coronavirus (COVID-19) outbreak, the CRCT will be working remotely. Please continue to direct all queries to us using the team mailbox at firstname.lastname@example.org.
- For COVID-19 guidance for clinical research, please see the Research Governance Team:
Latest news & updatesAtom Feed
- New Compliance Review SOP and Project Oversight & Quality Management SOP. These SOPs will both become effectiv as of 25-Oct-2021, and are applicable to clinical studies and clinical trials.
- Updated Training SOP, which will become effective as of 26-Jul-2021.
- Updated Project Closure SOP (effective as of 22-Mar-2021), Archiving SOP (effective as of 29-Mar-2021) and Adverse Event Reporting SOP (effective as of 19-Apr-2021). All now applicable to clinical studies and trials.
- Updated Randomisation and Blinding SOP; scope expanded to include clinical studies as well as clinical trials. This SOP will become effective as of 17-Aug-2020.
- Four SOPs and associated QCDs released: QMS Development and Management SOP, Healthy Volunteers & Medical Oversight SOP, Skeletal Muscle Biopsies SOP and Food & Nutritional Components SOP. All effective as of 20-Jul-2020.
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Statement on use of UoB as a site in regulated clinical trials
Please note that UoB would not normally act as a ‘site’ for regulated clinical trials or surgery trials (i.e. Clinical Trials of Investigational Medicinal Products (CTIMPs) or of medical devices).
While exceptions to this may occasionally be made, where an exception is made this will be documented in writing in a letter from the University’s Head of Research Governance and Integrity.
This means that no patients on CTIMPs, regulated device trials or surgery trials may be recruited, receive treatment or other interventions on University premises without the express written permission of the Head of Research Governance and Integrity.