The NICTU can provide specialist advice, support and training for investigators undertaking research within or of value to the HSC. In particular NICTU can support and co-ordinate multi centre clinical trials.
The NICTU team has a broad range of research expertise including trial management, statistics, data management, monitoring and health economics across clinical research in clinical, community and general practice settings.
Trial Management
- Protocol development
- Ethical, regulatory and research governance applications
- Establish and maintain trial master file (TMF)
- Trial oversight, co-ordination of TMG/TSC/DMEC meetings
- Trial supplies including IMP management
- Site selection, training and initiation
- Pharmacovigilance
- Progress and safety reports (funders, sponsors, ethics and regulatory authorities)
- Budget management
Data Management
- Development of case report form (CRF)
- Data management plan
- Development and validation of clinical trial database
- Data entry, validation and discrepancy management
- Screening and accrual reporting
Monitoring
- Risk assessments and development of trial monitoring plan
- Onsite and central monitoring activities
Statistics
- Trial design
- Sample size calculations
- Randomisation
- Statistical analysis plan
- Reports to TSC and DMEC
- Analysis, interpretation and reporting
Health Economics
- Full economic evaluations
- Partial evaluations
- Dissemination of results