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Cambridge University Hospitals NHS Foundation Trust improve record keeping efficiency for their Clinical Trials activities

Cambridge University Hospitals NHS Foundation Trust (CUH) is a partnership with one of the world’s leading universities. CUH supports the delivery of world-class excellence in research to improve national health outcomes.

The Cambridge Clinical Trials Unit (CCTU) supports academic investigators to conduct randomised, multi-centre clinical trials from conception, to protocol design, ethical and regulatory approvals, trial conduct, data management, statistical analysis and dissemination of results.

The NIHR Clinical Research Facility (CRF) as part of the Addenbrooke’s Clinical Research Center (ACRC), provides dedicated clinical areas where treating and assessing clinical trial patients across a wide range of clinical specialties takes place. Within the NHIR investigators conduct Clinical Trials of Investigational Medicinal Products, medical device trials as well as mechanistic, physiological, observational and qualitative research studies. The rather difficult to manage paper based quality management system (QMS) led to the conclusion that an electronic QMS would greatly facilitate the collation of the ever growing levels of often mandatory documentation to comply with Good Clinical Practice (GCP). In both units, the research teams require accurate and complete trial documentation, equipment records and training records relating to each project in line with regulatory requirements before during and after each research project.

 

  • Highest standards of compliance achieved, particularly in most recent MHRA GCP inspection with zero non-conformances found when scrutinising the system
  • The CCTU joined list of top research facilities by gaining registration with UK Clinical Research Collaboration network
  • Document and information retrieval in seconds, quickening and easing inspections from bodies such as MHRA
  • Up-to-date maintenance and equipment records

The accreditation of the Cambridge Clinical Trials Unit was a great achievement for us. Gaining registration by the UK Clinical Research Collaboration network added to our excellent reputation as one of the top research centres

Carolyn Sexton - Quality Assurance Manager
Cambridge University Hospital

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