Newcastle Clinical Trials Unit

Trial management and monitoring

Clinical Trial Management and Monitoring

We can support you with conducting your trial, through management and monitoring.

We can assist with:

  • development and implementation of randomisation strategy
  • 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
  • set-up and maintenance of trial web-sites
  • 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 & procedures
  • risk assessment
  • central and on-site monitoring
  • database and data management
    • design of Case Report Forms (CRFs), questionnaires, diaries etc
    • database design and programming
    • data queries and validation
  • organisation of TSC and DMC meetings
  • preparation and submission of progress reports and amendments to:-
    • funding body / Sponsor
    • MHRA
    • Research Ethics Committees
    • R&D departments in participating NHS trusts
  • submission of recruitment data to NIHR portfolio
  • in collaboration with IHS, statistical analysis
    • preparation of Statistical Analysis Plan
    • preparation of reports for Trials Steering Committee (TSC) and Data Monitoring Committee (DMC) meetings
    • tnterim analyses as  appropriate