Under the AcoRD principles, the funding arrangements for commercial contract research studies are straightforward: the HSC/NHS is required to recover all costs over and above the standard HSC/NHS Treatment Cost. Commercial research is costed and negotiated in Northern Ireland in line with the National Contract Value Review (NCVR) process.
What is NCVR?
The national contract value review (NCVR) is a standardised, national approach to costing for commercial contract research. The NCVR focuses on centrally agreeing the resources and price needed to set up commercial research studies within the HSC/NHS.
All commercial studies (with the exception of primary care) in the UK taking place in HSC/NHS organisations must undergo a standardised resource review as part of NCVR.
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There is no local HSC/NHS site price negotiation
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All commercial UK template agreements will include the new financial appendix
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The financial appendix is mandated for use, unmodified
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The IRAS and interactive costing tool (iCT) submissions will be made in parallel
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iCT national review is shared with applicant rather than with participating sites. The applicant copies the organisation-specific iCT finance schedule into the new template contract appendix, to be shared with participating sites. Sites will still receive the full organisation-level budget detail from the iCT, to support invoicing and internal funding allocations.
To date, the NCVR process has contributed to a reduction in the time taken to set up commercial research studies by 36% (12 month analysis). In addition to faster set up, NCVR has freed up resource at sites to carry out other research activity.
What about commercial contract research taking place in Primary Care?
NCVR remains a voluntary scheme for Primary Care organisations. As of September 2024, approximately 300 GP Practices in the UK have signed on to the scheme.
Work continues to support Primary Care to accept and embed the full NCVR process.
NCVR is a UK-Wide Programme
There is reciprocal recognition of the resource reviews conducted by HSC/NHS organisations across the UK. In Northern Ireland the process is overseen and delivered by the HSC R&D Approvals Service working closely with the Sponsor, Chief Investigator and Lead particpating organisation.
Sponsor Requirements
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Submit your iCT for study resource review at the same time as your IRAS submission
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Include the appropriate new UK template agreement, with the new financial appendix, in your IRAS submission. Do not use any previous agreements for any IRAS submission on or after 1st October 2023.
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Copy the iCT finance schedule, when available, into the financial appendix of the agreement to share with participating sites
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Complete the site iCT process, before sharing the locked-down site-level iCT with the site inside CPMS. This should be done at the same time as sharing the completed contract template with the site, to support site invoicing and internal disbursement
The interactive Costing Tool (iCT) includes:
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New functionality, including tiered R&D set up, coordination and close down fees and revised time-based calculations, replacing some unit costs.
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Investigations will uplift based on price variation and outsourcing analysis, with changes visible in the iCT tariff workbook
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The Market Force Factor for Northern Ireland is 1.20
Items such as participant travel or subsistence allowance will be pass through costs and not listed within the budget. The new UK finance appendix allows for sponsors to cap such pass-through costs per visit, with costs incurred over the cap requiring sponsor authorisation.
Further information
Contact
Please email the HSC R&D Approvals Service at NCVR@hscni.net if you have any questions about NCVR or about submitting a NI-led study for resource review.
For queries related to model template agreements, contract drafting, negotiation for clinical trials or collaboration projects in NI, please contact ResearchContracts@innovations.hscni.net.