The Northern Ireland Clinical Trials Unit grew out of the Clinical Research Support Centre which was established in 2004 to support health and social care researchers in Northern Ireland. We sharpened our focus to clinical trials in the late 2000s and achieved full registration status from the UK Clinical Research Collaboration (UKCRC) in 2013. Based in the Belfast Health and Social Care Trust (BHSCT) we provide a regional service and play an integral role in the research infrastructure of Northern Ireland.
Our UKCRC full registration status reflects our experience and capacity for coordinating multi-centre randomised controlled trials and other well-designed studies in collaboration with academic clinicians and health service researchers. We have a core team of expert staff to develop studies and robust quality assurance systems and processes in place to ensure we meet the relevant regulations.
We support all aspects of research from concept through to reporting. Types of support provided by our expert team include:
- Trial design
- Funding applications
- Trial management and co-ordination
- Protocol development
- Research ethics committee (REC), Regulatory (MHRA) and NHS/HSC Trust R&D applications
- Establish trial oversight committees on behalf of the Sponsor and Funder
- Site identification
- Site training and initiations
- Case report form design
- Database design and development
- Data management (including data entry)
- Statistical analyses
- Health economic evaluation
- Report writing and publication
- Quality assurance
Funding
There are two strands of income for the NICTU: core support from the Northern Ireland Public Health Agency Research and Development Division and research grants. Our main research grant funder is the National Institute for Health and Care Research (NIHR).