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Healthcare research studies

Healthcare research studies The Healthcare Research Studies web pages provide guidance and resources to help investigators meet benchmark targets set by the NIHR. A combination of process maps, task outlines, checklists and recommended contacts will help researchers negotiate a path through a complex system of submissions and approvals.

Maps

Route maps

  • College sponsored
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Stages

Stages

  • Feasibility assessment
  • Study work-up
  • Governance
  • Patient recruitment
Stakeholders

Stakeholders

  • ICHT Clinical Dvisions
  • JRCO
  • Pharmacy
  • Imaging research
  • Tissue Bank
  • Pathology
  • ICTU
  • Research facilities
  • Information governance
  • New Interventions Committee
Resources

Resources

  • Documas
  • NIHR benchmarks
  • Documentation

Healthcare research studies

  • Maps
    • ICL sponsor
    • ICHT sponsor
    • Commercial sponsor
    • Non-commercial sponsor
  • Stages
    • Feasibility stage
      • Develop research idea
      • Develop protocol
      • Site opportunity
      • Confirm sponsorship
      • Assess feasibility
      • Assess resources/capacity
      • Assess costing
      • Enter on Documas
      • Confirm portfolio eligibility
      • Advise on College costs
      • Divisional review
      • Advise service costs/feasibility
      • Review costing
      • Assist with feasibility
      • Confirm feasibility
      • Cancel study
      • Submit feasibility assessment
      • Approve study work-up
      • Complete funding application
      • Negotiate service agreements
      • Negotiate contract
      • Approve grant application
      • Submit funding application
    • Work-up stage
      • Funding awarded
      • Coordinate study work-up
      • Sign contract
      • Plan patient recruitment and logistics
      • Prepare study documents
      • Prepare to hire study staff
      • Reaffirm feasibility (at work-up)
      • Process request for services
      • Set-up award
      • Arrange peer review
      • Advise on documentation
      • Complete study work-up
      • Approve IRAS submission
      • Submit IRAS REC and R&D
      • Submit IRAS SSI
      • Process external approvals
    • Governance stage
      • Log receipt (valid IRAS submission)
      • Initiate governance review
      • Finalise patient recruitment and logistics
      • Resolve study queries
      • Reaffirm feasibility (at governance)
      • Check policy and legal requirements
      • Confirm contract and finance
      • Confirm service approvals
      • Verify external approvals
      • Complete governance review
      • Cancel study (at governance stage)
      • Issue Trust approval
      • Brief trial team
    • Recruitment stage
      • Initiate project
      • Initiate site
      • Activate funding
      • Initiate recruitment
      • First Patient First Visit
      • Capture subject accruals
      • Report into Documas
      • Monitor trial
      • Review amendments
      • Undertake financial management
      • Last Patient Last Visit
      • Close site
      • Reporting
      • Archiving and publication
  • Stakeholders
    • Clinical Divisions
    • Research Governance and Integrity Team
    • Pharmacy
    • Imaging research
    • Tissue Bank
    • Pathology
    • Imperial Clinical Trials Unit (ICTU)
    • Research facilities
    • Information governance
    • New Interventions Committee
  • Resources
    • Clinical research studies (Documas)
    • NIHR benchmark
    • Documentation
    • Healthcare research guidance
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