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Brighton & Sussex Medical School

How we can help

BSMS > Research > Brighton and Sussex CTU > How we can help

How we can help

Clinical trial development

In conjunction with the RDS, we can assist with:

  • Study design, including patient-related outcome research (please contact SHORE-C)
  • Guidance on ethical issues
  • Guidance on planning for compliance with regulatory and governance requirements
  • Guidance on feasibility issues (in collaboration with the NIHR Clinical Research Networks)
  • Advice on Investigational Medicinal Product (IMP) management (including referral to NHS Trust pharmacy and procurement services)
  • Advice on resource requirements
  • Costing the proposal, in collaboration with University and NHS Trust finance colleagues
  • Planning and scheduling study timelines and milestones
  • Advice on role and membership of Trial Safety Committee (TSC) and Data Management Committee (DMC)

Trial set-up

We can assist with:

  • Assistance with turning proposal for funding into full protocol
  • Development of data capture forms and systems
  • Programming/set up of trial databases
  • Preparation of Statistical Analysis Plan
  • Development of trial-specific manuals of procedures and standard operating procedures
  • Assistance with application to MHRA
  • Registering study with EUDRACT
  • Preparation and submission of Clinical Trial Application (CTA) application
  • Assistance with application for ethical approval
  • Preparation of Patient Information Sheet (PIS) and Consent Forms
  • Guidance on obtaining NHS Permissions
  • Advice on obtaining honorary NHS contracts/research passports as required
  • Registration of the trial on a publicly accessible database/register
  • Assistance with applications for other permissions and approvals as required
  • Set-up of Trial Master File
  • Liaison with trial sites
  • Assistance with investigator meetings and site initiation visits

Trial conduct

We can assist with:

  • Development and implementation of randomisation strategy
  • Management of Investigational Medicinal Product and supplies
  • Patient recruitment and retention, including design of recruitment and retention strategies and informed consent procedures
  • Ongoing communication with trial sites and investigators
  • Preparation of trial newsletters
  • Set-up and maintenance of trial websites
  • Adverse event monitoring and reporting
  • Ensuring that requirements for MHRA/ethics/research governance are complied with
  • Designing and implementing appropriate systems for monitoring and reporting
  • Training trial personnel in implementation of study protocol and procedures
  • Risk assessment
  • Monitoring (central and site monitoring)
  • Database and data management
  • Design of Case Report Forms (CRFs), questionnaires, diaries etc
  • Database design and programming
  • Data queries and validation
  • Statistical analysis
  • Preparation of reports for Trial Safety Committee (TSC) and Data Management Committee (DMC) meetings
  • Interim analyses as appropriate
  • Organisation of TSC and DMC meetings
  • Assistance with preparation and submission of progress reports and amendments to: funding body/sponsor; MHRA; research Ethics Committees; R&D departments in participating NHS trusts
  • Submission of recruitment data to NIHR portfolio

Trial analysis, reporting and close-down

  • Statistical analysis
  • Contribution to preparation of final reports to regulatory bodies
  • Final publication
  • Archiving
  • Long-term storage of trial data
BACKGROUND IMAGE FOR PANEL

The role of Clinical Trials Units in developing an NIHR funding application