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.

Our services

Design and Funding

We work with you from the early stages of your ideas, providing input to; trial design, feasibility, sample size and statistical analysis, qualitative (mixed methods) components, ethics and regulatory requirements, costings for proposals, resource planning and timelines, funding applications.

Study Management and QA

We help researchers to build their capacity by leading the set-up and management of trials. Experienced trial management staff will input to; protocol development, PPI participation, risk assessments, obtaining regulatory approvals, processing amendments, site contracting, site set-up, trial QA and site monitoring, trial safety reporting and pharmacovigilance, coordinating trial logistics, budget management, study reporting and coordinating trial oversight committee meetings.

Data Management

Working with our data management team, you can access a suite of regulatory compliant information systems to allow the efficient development and delivery of your research project. We will work with you to; design workflows, eCRF and database, coordinate data queries and data cleaning, export data for reporting and analysis.

Data Capture

We use a regulatory compliant cloud based electronic data capture system, REDCap Cloud. Data can be entered remotely by your study staff or participants from any computer or device (tablets and mobile), facilitating efficient and accurate data collection. REDCap incorporates; eCRF, patient information, eConsent, randomisation, surveys, data import and reporting.

Data Safe Haven (DSH)

Our DSH is a safe and secure environment for storage and processing of data sets requiring compliance with NHS Information Governance (DSP) toolkit standards. We provide a controlled environment, access to all necessary software and the option of support from HHTU data specialists to help with linkage and anonymisation.

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Randomisation

REDCap Cloud provides a regulation-compliant web-based randomisation, which is accessible 24 hours per day. The system can support blinded randomisation from simple blocks through to complex minimisation. It can integrate screening and data collection for a seamless path from first contact through to follow up in one system.

Collaboration tools

We provide a suite of regulatory compliant services to allow the efficient development and delivery of your research project, this includes; secure collaborative cloud based storage with full audit trail and document control, eSignature to facilitate approvals process, remote data capture and a secure data safe haven.

Statistical analysis

We provide expert statistical collaboration for all HHTU trials and can develop your analysis plan. Our statistical input into your research is vital to ensure that your data is collected and analysed accurately and most importantly will ensure your results are publishable in high impact journals.

Reporting and dissemination

Throughout your trial we can assist with; preparation and submission of progress reports, amendments and close out reports to funding body/sponsor; MHRA; research ethics committees; R&D departments in participating NHS trusts. We can host trial webpages, create newsletters and contribute to, and coordinate the publication of results.

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

HHTUenquiries@hull.ac.uk

+44 (0)1482 463444

Enquiry form