our-services

Study support

We provide a range of practical and specialist support throughout the clinical research process, helping researchers at all stages of their study.

Here at the HHTU we believe a full collaboration will allow us to deliver the maximum benefit to your research project, however we recognise that in some circumstances this may not be feasible. In those cases HHTU can offer access to specific services and would be pleased to discuss them in more detail.

Trial design, management and analysis

Trial design and development

We can assist with

  • study design including economic evaluation and qualitative components
  • guidance on ethical issues and compliance with regulatory and governance requirements
  • guidance on feasibility issues, development of participant selection, strategies and sample sizes (randomisation options)
  • plan and schedule study timelines and advise on resource requirements
  • costing the proposal, in collaboration with University and NHS Trust finance colleagues
  • advice on role and membership of Trial Safety Committee (TSC) and Data Management Committee (DMC)
Trial setup

We can assist with

  • trial protocol development
  • statistical analysis plans including randomisation systems
  • Electronic Data Capture database build, test and release
  • site selection, feasibility assessments and site set up
  • finance and contractual arrangements
  • submission of regulatory approvals (e.g. REC, CAG, MHRA, HRA)
  • Standard Operating Procedure (SOP) development
  • risk assessments and risk mitigation plans
  • vendor assessments such as Pharmaceutical / device manufacture, central laboratories
  • coordination of Oversight Committee meetings
Trial conduct and management

We can assist with

  • implementation of trial protocols
  • monitoring study compliance in line with GCP, MHRA guidelines and trial protocols
  • protocol amendments
  • resolution of data queries
  • interim and final data analysis
  • trial progress reports
  • trial financial management
  • Quality Assurance audits and / or MHRA inspections
  • Vendor and Risk Assessments
  • Coordination of Trial Safety Committee, Trial Management Group, Data Management Committee
  • liaison with Public Patient Involvement (PPI) members
Trial analysis, reporting and closedown

We can assist with

  • interim and final data analysis
  • final study reports
  • finance transaction reports
  • final payments to sites, vendors and partners
  • close out procedures
  • archiving of trial documentation
  • dissemination of results through publications and presentations in peer reviewed journals or at national and international conferences
  • dissemination of trial findings to sites, participants and study partners

Standard operating procedures (SOPs)

SOPs are an essential element for the quality control of clinical research from planning through to study closure, and for all the activities which support the clinical research process.

Contact

Hull Health Trials Unit
3rd Floor AMB
University of Hull
Hull
HU6 7RX
UK