University of Dundee
Tayside Clinical Trials Unit (TCTU)
TAyside medical Science Centre
TASC Research & Development Office
Ninewells Hospital & Medical School
Residency Block, Level 3
George Pirie Way
Dundee, United Kingdom
The Tayside Clinical Trials Unit (TCTU) was established in October 2008 as a collaboration of the University of Dundee and NHS Tayside to deliver excellence in the design, conduct and governance of clinical trials. TCTU is directed by Professors David Bearn and Peter Donnan and consists of the TCTU central office comprising of experienced trial managers, trial statisticians, data base developers and administrative staff. Other TCTU members of staff are embedded within the clinical trial teams.
TCTU provides support to research staff locally, nationally and internationally undertaking clinical trials of investigational medicinal products (CTIMPs) and non-CTIMP randomised controlled trials. TCTU offers investigators scientific, funding, technical and IT expertise from conception of the trial to analysis and reporting. A choice of support service is available for investigators, tailored to the level of support required, ranging from data management systems or statistical analysis through to full trial design and management.
TCTU offers specific advice and expertise in:
- Study design: recruitment strategy, sample size
- Trial Documentation: Protocol review, patient information sheets, case report forms
- Data Management: capture, storage, transfer, cleaning, independent data monitoring
- Statistical: design and interim and final analysis
- Approvals: ethical, regulatory and local governance
- Contractual management: provision of services, supply of medicinal product, academic collaboration
- Trial Management and Co-ordination: working with sites, processing amendments, establishing trial committees
- Funding: identification of potential funding sources and input to funding application
- Training and Mentoring: overarching and bespoke training and mentoring for clinical researchers, trial managers, co-ordinators and research nurses
TCTU also works closely with other University of Dundee and NHS Tayside units and facilities including the Dundee Epidemiology and Biostatistics Unit (DEBU), Health Informatics Centre (HIC) and Clinical Research Facility (CRC). TCTU is active in drug trials and complex interventions across a broad spectrum of disease areas including cardiovascular, diabetes, oncology, aging and health, paediatrics and dentistry.
The TCTU was awarded full registration in August 2012 by the UKCRC, the UK body responsible for the external review of all trials units in the UK.