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).

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Serious Breach Reporting

As per the Deviation and Serious Breach Reporting SOP (Word - 74 KB), all serious breaches must be reported to the Research Governance and Ethics Team: 

UoB as a site in regulated clinical trials

As per the Clinical Research Quality Manual (Word - 559 KB), the 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.