Kent & Medway CLRN is funded by the NIHR CRN Coordinating Centre (NIHR CRN CC) to deliver an integrated, high quality, efficient research management and governance service, which meets the needs of researchers and the Member Organisations participating in NIHR activity and supports the national objective to deliver Faster, Easier Clinical Research.This means there is a standardised system for local management NHS permission (also known as R&D approval), which is required for all research hosted locally (‘assurance’ for primary care).The Research Governance Framework sets out the responsibilities of the NHS to deliver a research governance function for all clinical research within the NHS.The CLRN is measured on its achievement against certain key targets, including time to NHS permission
Kent & Medway operates a devolved model of research management and governance, which means that Member Organisation R&D departments are funded to deliver national systems and processes.Local investigators should always approach their R&D department in the first instance for advice, support and signposting.This includes, but is not limited to, the permission process and amendments, including arrangements for local authorisations, and HR arrangements (e.g. Research Passports).Our local CLRN funded RM&G staff are linked in to national developments and are all trained to the expected high national standard in specific sets of legislation such as the Human Tissue Act, Mental Capacity Act, Radiation Guidelines and Confidentiality, Privacy and Data Protection.
Some core activities are also provided by a small RM&G team based at Gillingham Business Park.
Hazel Crawford, RM&G Manager
Telephone: 01634 350419
Reports on achievement against key targets
Works with devolved teams to implement national initiatives to standardise and streamline processes.
Training and support for RM&G staff
Oversight of Lead CLRN role (Study Wide CSP Review, for local Chief Investigators)
Oversight of Coordinated Network Support Service and pre-application support (supporting correct cost attribution and ensuring arrangements in place for service support across all participating sites, for local Chief Investigator)
Linda Partington, CSP and GCP Facilitator
Telephone: 01634 350422
Supports RM&G staff with achieving CSP targets and CSP issues.
Supports investigators with applying for NIHR GCP training.
Hayley Crittenden, RM&G Administrator Email: firstname.lastname@example.org
Meeting set up and general administration support.
Here are some useful hints which may help you to prevent delays.
Pre-application advice – for new studies you can e-submit a draft R&D or SSI Form, supporting documents and checklists directly from IRAS to the CSP Module at an early stage so the relevant CLRN can offer guidance and support before you make your final submission.
Costing templates – If the Costing Template is not included with your R&D submission because it has already been shared with the NIHR Clinical Research Network please use the comments box of the IRAS Checklist to explain this.
When submitting your R&D and/or SSI Forms through IRAS please include all the documents listed on the appropriate IRAS checklist.
Good Clinical Practice Training - We provide GCP and Valid Informed Consent training for researchers – further details and dates.
Find out more about NIHR CSP We ensure that all quality assurance and statutory requirements in respect of clinical research are met, through standardising and streamlining the process for gaining NHS Permission in England. CSP Helpdesk email@example.com
The process for handling amendments for studies that have gained approval through the NIHR CSP has been revised. The revised process sets out a clear timeline and consistent approach for handling amendments.
Integrated Research Application SystemA single system for applying for all the permissions and approvals for health and social care/community care research in the UK.IRAS uses filters to help applicants meet regulatory and governance requirements.
Coordinated Network Support for Chief Investigators Coordinating study set-up across the Network for Chief Investigators.
Research Passport and HR Arrangements.Streamlined arrangements for Researchers working across NHS organisations.
Research Support ServicesConsistent and risk proportionate framework for Research Management.
Research Governance Framework- sets out the role of research and broad principles for good research governance in the NHS.
NIHR CRN Portfolio eligibility criteria For inclusion of studies in the NIHR CRN Portfolio.
Model Contracts Information about Model Contracts are available on the UK Clinical Research Collaboration (UKCRC) website. The NIHR advises the use of the model Clinical Trial/Clinical Investigation Agreements which speed up contracting between companies and NHS organisations. These agreements are designed to be used ‘off the shelf’, without modification and are available for a range of various research scenarios.
Industry Costing Templates Designed to speed up initiation of industry contract trials by increasing transparency and predictability and by reducing the time required for site-by-site negotiations.
For Support for Industry Studies providing expert guidance during feasibility, set-up and management of studies.
Through the Clinical Research Network, researchers have access to a wide range of support at the planning, set-up and delivery phases of a study. The information on this page is primarily aimed at non-commercial researchers (that is, those who are based in universities, the NHS or public sector organisations).
The NIHR Research Design Service (RDS) supports researchers to develop and design high quality research proposals for submission to NIHR and other national, peer-reviewed funding competitions for applied health or social care research.
Leaflet on Timely Study Set-Up with information on targets to gain NHS permission and tips on how to help achieve them. Timely Study Setup 1213 FV.PDF