Newcastle Clinical Trials Unit

Trial Set-Up

Clinical Trial Set-Up

We offer support to help you set up a clinical trial.

We can assist with:

  • turning a proposal for funding into a full protocol
  • development of data capture forms and systems
  • programming/set up of trial databases
  • acquisition of questionnaires
  • development of trial-specific manuals of procedures and standard operating procedures
  • application for NIHR portfolio adoption
  • application to MHRA
    • registering study with EUDRACT
    • preparation & submission of CTA application
  • application for ethical favourable opinion
    • preparation of Patient Information Sheet and Consent Forms
    • completion and submission of REC form
  • application for Trust R&D approval, via CSP
    • preparation of ‘global’ R&D form
    • guidance on completion of Sites Specific Information Forms where appropriate 
  • advice on obtaining honorary NHS contracts / research passports as required
  • registration of the trial on a publicly accessible database/register
  • applications for other permissions and approvals as required
  • set-up of Trial Master File
  • liaison with trial sites
  • investigator meetings and site initiation visits