Quality Assurance

The University of Oxford is one of the leading clinical research centres in the world and the Oxford Brain Health Clinical Trials Unit (OBHCTU) resides within the Department of Psychiatry, Division of Medical Sciences. OBHCTU is committed to working with academic and clinical researchers from within the University of Oxford as well as external researchers, and aims for all their adopted research studies and other research services to be conducted to a high-quality standard.

Within research, Quality Assurance plays an essential part in ensuring that there are planned and systematic actions to guarantee that accurate data is generated and documented, and that it is reported reliably. All trials within OBHCTU are conducted in line with UK and international clinical trial regulations and legislation, and in compliance with Good Clinical Practice. This is a set of internationally recognised ethical and scientific quality standards for the design, conduct and reporting of clinical trials.

To ensure that there is continual improvement of our quality processes and procedures, OBHCTU has implemented a Quality Management System (QMS). OBHCTU was successfully granted ISO 9001; 2015 accreditation by the BSI in early 2020 for its QMS. We are proud to use this framework to continually deliver high quality research both efficiently and effectively.

Within the Quality Assurance team at OBHCTU, the Quality Assurance manager is independent to the rest of the unit and is responsible for maintaining procedures and records, as well as providing advice and guidance on all aspects of clinical trial delivery to study teams. All OBHCTU staff are responsible for ensuring  that their work is conducted in line with the OBHCTU Quality Management System and that standards of quality are being reached.