Newcastle Clinical Trials Unit

Clinical Trial Set-Up

Clinical Trial Set-Up

We will work with you to set up clinical trials and studies:

  • turning a proposal for funding into a full protocol
  • developing consent forms and patient information sheets (PIS)
  • feasibility
  • risk assessments
  • development of data capture forms and systems
  • programming/set up of trial databases
  • development and implementation of randomisation strategy
  • acquisition of questionnaires
  • development of trial-specific manuals of procedures and standard operating procedures (SOPs)
  • development of trial-specific documentation (e.g. delegation logs, monitoring plans, data management plans)
  • set-up of supporting departments and documentation required (e.g. Laboratory Manual, delegation logs)
  • application for NIHR portfolio adoption
  • application to MHRA, HRA/HCRW and Research Ethics Committee (REC)
  • registering study with EUDRACT
  • completing IRAS to apply for permissions and approvals
  • registration of the trial on a publicly accessible database/register (e.g. ISRCTN)
  • applications for other permissions and approvals as required
  • set-up of Trial Master File (TMF)
  • set-up of Investigator Site Files (ISF)
  • liaison with trial sites, including international sites
  • investigator meetings and site initiation
  • Contract/agreement negotiation and approvals
  • establish trial oversight committees (e.g. TSC, IDMC, TMG)
  • training trial personnel
  • green lighting of trial sites