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).

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.

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.

We can assist with: