Information for researchers

All research in the Trust must conform to high clinical, ethical and governance standards and be fully compliant with appropriate legislation. The Research and Development team has a lot of experience in supporting clinical research. One of our main jobs is to provide researchers with help and advice to overcome the bureaucracy that can be associated with undertaking research. Discuss your research with us and we will do all we can to help. By working together we can increase our high quality research for the benefit of our patients.

The Study Setup Team

The team work alongside Principal Investigators and research teams to ensure studies are set up in a reasonable time frame. Researchers are provided with dedicated points of contact (Clinical Trials Officers) and they are available to support you throughout the study set up process. The team will also facilitate contract negotiations to ensure studies are financially supported. Their main tasks involve but are not limited to:

  • Setting up commercial and non-commercial research trials
  • Budget negotiations
  • Supporting departments costs and approval
  • Site selection visits
  • Amendments
  • Study setup and administration support

For any queries relating to non-sponsored research please email R&D@uhcw.nhs.uk

The Governance and Sponsorship Unit

The Governance and Sponsorship Unit work closely with chief investigators and research teams to provide support for study development, pre-trial guidance, feasibility and capability assessments for sponsored research. They also support you with obtaining Trust sponsorship, HRA and REC approval. The team (alongside the study setup team) also work on arranging approvals for student projects, GafREC and service evaluations, Honorary Research Contracts and Letters of Access.

The Governance unit also work on completing risk assessments for all trust sponsored studies, creating and maintain SOP’s & Work statements, Contractual site agreements, Audit and monitoring, DATIX reports/investigations.

For any queries relating to governance or sponsored research please email R&DSponsorship@uhcw.nhs.uk

Trial Management Team

Effective trial management ensures that all the critical elements of a trial are coordinated to ensure its successful delivery on time, within budget and to a high standard.

Our Trial Management team provide dedicated support and assistance to researchers throughout the research process from initial concept through to trial completion, including:

  • Study design and feasibility
  • Protocol development
  • Ethics and approvals
  • Safety reporting
  • Study conduct
  • Data management
  • Patient recruitment and follow-up
  • Analysis and reporting

Trials can be initiated by clinicians/researchers (i.e.Trust sponsored studies) or may be initiated by other academic, healthcare or pharmaceutical partners.

If you are interesting in discussing trial management support for a trial, particularly if you are applying for grant funding please Contact Us early to discuss your proposal.

The NIHR Coventry and Warwickshire CRF

The CRF team provides the support and expertise needed to conduct high quality experimental medicine studies at University Hospitals Coventry and Warwickshire NHS Trust.

Studies supported by the CRF include:

  • Early phase interventional studies (phase IIa and earlier)
  • Experimental medicine studies ‘nested’ within later phase studies which require specialised facilities, staff or equipment
  • The high-intensity or high-complexity elements of later-phase studies
  • Early stages of testing new techniques or new medical devices
  • The NIHR Coventry & Warwickshire CRF team supports studies within:
  • Clinical Research Treatment Centre
  • Patient Research Interface Suites
  • Human Metabolic Research Unit (HMRU)
  • Biomedical Research Unit (BRU) in Reproductive Health
  • Arden Tissue Bank
  • Other areas which carry out experimental medicine studies

Having a NIHR supported CRF provides several benefits and opportunities to patients, researchers and the Trust, including:

  • Access to high quality experimental medicine studies, brand new treatments, diagnostics and care
  • Expert support for planning and conducting early phase research
  • Reassurance that early phase research is conducted to a high quality
  • Increased funding for infrastructure / support costs
  • Access to expertise of the NIHR UKCRF Network – e.g. training, sharing best practice and documentation

To discuss how the NIHR Coventry & Warwickshire CRF can support your study please contact: coventryandwarwickshirecrf@uhcw.nhs.uk

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