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Newcastle Clinical Trials Unit
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Supporting Clinical Trials

NCTU support high quality, innovative research. We provide a bespoke service to researchers, sponsors and industry partners through all stages of a trial, from trial design and application for funding, through trial set-up to trial conduct, analysis, reporting and close-down.

Clinical Trial Design

In conjunction with NIHR Research Design Service North East and North Cumbria we can assist with: 

  • identifying the appropriate funding stream(s)
  • refinement of research questions
  • choosing the most appropriate study design
    • trial design
    • including an economic evaluation component
    • including a qualitative component
  • development of participant selection, strategies and sampling
  • choosing the most appropriate outcome measures
  • planning for compliance with regulatory and governance requirements
  • guidance on ethical issues
  • guidance on feasibility issues, in collaboration with the NIHR Clinical Research Networks
  • evidence synthesis/systematic review
  • IMP procurement, including referral to NHS Trust pharmacy and procurement services
  • advice on resource requirements
    • distinguishing between research, NHS support and treatment costs
    • costing the proposal, in collaboration with University and NHS Trust finance colleagues
    • planning and scheduling study timelines and milestones
  • advice on the role and membership of Trial Oversight Committees
    • Trial Steering Committee (TSC)
    • independent Data Monitoring and Ethics Committee (DMEC)
  • advice on presenting the application to funders

We have experience of applying to the following funding streams:

NIHR

  • Health Technology Assessment (HTA)
  • Efficacy and Mechanism Evaluation (EME)
  • Research for Patient Benefit (RfPB)
  • Programme Grant for Applied Research (PGfAR)
  • Fellowships
  • Invention and Innovation (i4i)
  • Public Health Research (PHR)
  • Health Service and Delivery Research (HS&DR)

MRC

  • Development Pathway Funding Stream (DPFS)

Charities

  • British Heart Foundation
  • Arthritis Research UK
  • Heart Research UK
  • Cancer Research UK
  • Diabectics Research UK

We also have experience of working on commercial Investigator Initiated Trials (IIT).

We work closely with the following sponsors:

As a UKCRC Registered CTU based in England, and with a strong track record in winning funding from the NIHR funding streams managed through NETSCC, NCTU is in receipt of NIHR Clinical Trials Unit Support Funding, which provides pump-priming resourses.

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
Clinical Trial Analysis

We can facilitate the accurate analysis and reporting of a wide range of trials.

We work in close collaboration with researchers in the Newcastle University Population Health Sciences Institute:

Clinical Trials Conduct, Management and Monitoring

We conduct high quality trials and studies, through management and monitoring:

  • amendment preparation and approvals
  • 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
  • risk assessment review
  • set-up and maintenance of trial web-sites
  • maintenance of TMF and ISF
  • 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 and procedures
  • all aspects of trial monitoring (central, off-site/remote and on-site monitoring)
  • monitoring of supporting departments (e.g. Pharmacy, Laboratories)
  • deviation and violation management
  • database and data management
    • database changes
    • data queries and validation
    • data downloads
  • preparation and submission of progress reports and amendments to:-
    • funding body / Sponsor
    • MHRA
    • Research Ethics Committees
    • R&D departments in participating NHS trusts
  • review and confirmation of recruitment data for NIHR portfolio
  • in collaboration with Trial Statisticians
    • prepare reports for Trials Steering Committee (TSC) and Independent Data Monitoring Committee (IDMC) meetings
    • interim analyses as  appropriate
  • organisation of TSC, TMG and IDMC meetings
  • project management
Clinical Trial Reporting and Close-down

We will work with you in managing all aspects of reporting and close-down:

  • closedown of trial sites
  • closedown of supporting departments
  • database lock
  • contribution to preparation of final report
  • contribution to preparation of papers and other outputs for journals and conferences
  • project close-down reports to funders, MHRA and research ethics committees
  • End of trial declarations
  • Trial Master File (TMF) archiving
  • data archiving and preparation of data for sharing
  • data anonymisation
  • financial reconciliation
  • dissemination of results to participants