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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QMS - two new SOPs

QMS - two new SOPs
Description
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.
Date:
08/10/2021

QMS - updated Training SOP

QMS - updated Training SOP
Description
Updated Training SOP, which will become effective as of 26-Jul-2021.
Date:
13/07/2021

QMS - three recently updated SOPs

QMS - three recently updated SOPs
Description
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.
Date:
12/04/2021

QMS - updated Randomisation & Blinding SOP

QMS - updated Randomisation & Blinding SOP
Description
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.
Date:
05/08/2020

QMS - four new SOPs

QMS - four new SOPs
Description
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.
Date:
05/08/2020
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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.

Serious Breach Reporting

As per the Deviation and Serious Breach Reporting SOP (Word - 68 KB), all serious breaches must be reported to the Research Governance and Ethics Team: 

Also in 'CRCT'

Glossary of Terms  Useful Links UoB Clinical Research Oversight Committees