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