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Brighton & Sussex Medical School

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:

  • 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
  • the application to MHRA
  • registering the study with EUDRACT
  • preparation and submission of Clinical Trial Application (CTA) 
  • 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
  • applications for other permissions and approvals as required
  • set-up of Trial Master File
  • liaison with trial sites
  • 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
  • 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

We can assist with:

  • 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