Services

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