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TCTU Support Services

                     

 

TCTU can offer support and guidance in the development and running of investigational medicinal product (CTIMPs) and non-CTIMP randomised controlled trials.

TCTU offers specific advice and expertise in:

  Study design: recruitment strategy, sample size
  Trial documentation: Protocol review, patient information sheets, case report forms
  Data management: capture, storage, transfer, cleaning, independent data monitoring
  Statistical: design and interim and final analysis
  Approvals: ethical, regulatory and local governance
  Contractual management: provision of services, supply of medicinal product, academic collaboration
  Trial management & co-ordination: working with sites, processing amendments, establishing trial committees
  Funding: identification of potential funding sources and input to funding application
  Training & mentoring: overarching and bespoke training and mentoring for clinical researchers, trial managers, co-ordinators and research nurses

Monitoring and Pharmacovigilence are carried out as part of the close collaboration with NHS Tayside under TASC.