Newcastle Clinical Trials Unit

Clinical Trial, conduct, management & monitoring

Clinical Trials Conduct, Management and Monitoring

We conduct high quality trials and studies, through management and monitoring:

  • amendment preparation and approvals
  • patient recruitment and retention, including design of
    • recruitment and retention strategies
    • informed consent procedures
  • ongoing communication with trial sites and investigators
  • preparation of trial newsletters
  • risk assessment review
  • set-up and maintenance of trial web-sites
  • maintenance of TMF and ISF
  • adverse event monitoring and reporting
    • ensuring that compliance with MHRA / ethics / research governance requirements
    • designing and implementing appropriate systems for monitoring and reporting
  • training trial personnel in implementation of study protocol and procedures
  • all aspects of trial monitoring (central, off-site/remote and on-site monitoring)
  • monitoring of supporting departments (e.g. Pharmacy, Laboratories)
  • deviation and violation management
  • database and data management
    • database changes
    • data queries and validation
    • data downloads
  • preparation and submission of progress reports and amendments to:-
    • funding body / Sponsor
    • MHRA
    • Research Ethics Committees
    • R&D departments in participating NHS trusts
  • review and confirmation of recruitment data for NIHR portfolio
  • in collaboration with Trial Statisticians
    • prepare reports for Trials Steering Committee (TSC) and Independent Data Monitoring Committee (IDMC) meetings
    • interim analyses as  appropriate
  • organisation of TSC, TMG and IDMC meetings
  • project management