Research Initiation and Study Set-up

We implemented a streamlined the process of gaining NHS permission for research studies by reducing bureaucracy but retaining governance, oversight and accountability.

Research Study Initiative

The mission of The Clatterbridge Cancer Centre is to ‘improve health and wellbeing through compassionate, safe and effective cancer care’. The delivery of research for patient benefit is fundamental to our vision to ‘provide the best cancer care to the people that we serve’. The National Institute for Health Research (NIHR) and the Department of Health are increasingly challenging NHS Trusts to deliver ‘faster and easier’ clinical research. We provide proportionate, robust governance to assure compliance with legislation combined with a proactive, rapid delivery of research studies through the NHS permission process that supports the goals of the North West Coast Clinical Research Network (NWC CRN) enabling the NIHR targets and set High Level Objectives (HLOs).

We have a centralised, fully integrated governance system for study set-up and oversight; enabling accurate, real time reporting on study progression and recruitment to time and target using the Edge Platform customised for CCC use.

We implemented a streamlined the process of gaining NHS permission for research studies by reducing bureaucracy but retaining governance, oversight and accountability. The process is shown in the diagram below.

The Research Management and Governance Team assure robust, rapid set up of studies and are available for help, advice and enquires on all aspects of study management:

Lorraine Broadfoot, Research Partnerships Manager

Lorraine.Broadfoot@clatterbridgecc.nhs.uk

Gaynor Byrne, Trial Facilitator

Gaynor.Byrne@clatterbridgecc.nhs.uk

Approvals Facilitator: TBC

Jane Knight, Research and Development Administrator (and Trials Archivist)

Jane.Knight@clatterbridgecc.nhs.uk

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Information for CCC Researchers: Process for Gaining NHS Permission at CCC: information for Chief and Principal Investigators

  1. The PI or CI should register the study with the Research Management and Governance (RM&G) Team, by emailing the Research Administrator and requesting a Study Registration Form.
    • Please give details of the name of the study, phase and contact details of the CRA or Trial Co-ordinator.
  2. The PI/CI should complete the Registration Form and return via email to the Research Administrator.
  3. If the study is Early Phase (FiH, Phase I, IB or II), the PI/CI should complete a Risk Assessment for the Study, which will be sent out by the Research Administrator.
    • The study will not proceed through the process of gaining NHS permission until the Risk Assessment is completed and signed off by the Medical Director and Director of Chemotherapy.
  4. The Trial Facilitator or Research administrator will contact the PI/CI and arrange a meeting to complete the CCC local feasibility form as soon as all essential documents are available (REC form, Protocol, PIS, ICF).
  5. The Resource Committee will review the study.
  6. Once reviewed and resource agreed the Approvals Facilitator or Research Partnerships Manager if the study is Sponsored by a non-commercial or commercial organisation respectively, will steer the study through the NHS Permissions process according to current SOPs and Work Instructions.
  7. It is expected that the PI/CI will be available to respond to all queries and sign off all requested documents from the RM&G team in a timely manner to ensure optimal study set-up times.