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. However, the way commercial research is costed and negotiated in Northern Ireland and across the UK has recently changed, with an aim to improve consistency and reduce time to study set up through 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 replacing the previous process whereby each HSC/NHS organisation negotiated with each commercial sponsor for every study in order to agree bespoke contract value. The NCVR process will streamline commercial research setup, making the UK a more attractive place for international commercial organisations to undertake research studies thereby ensuring our patients have rapid access to cutting edge treatments.
All commercial studies in the UK must undergo a standardised resource review as part of NCVR. There is reciprocal recognition of contract value reviews conducted by HSC/NHS organisations across the UK.
Stage One
Stage One of NCVR has completed. Stage one was implemented from 1 October 2022 – 01 October 2023. In the first six months of NCVR, over 200 studies underwent NCVR study resource review. The average time to complete the study resource review was 29 days. As a result, the time taken from costing submission to first patient recruited was reduced by 45% (from an average of 213 days to 118 days).
To date, NCVR has not only helped to deliver faster site set up but has also freed up resource in sites to carry out other research setup and delivery activities.
Stage Two
Stage Two of NCVR is currently active. For all studies in the scope of Stage Two:
- There is no local NHS site price negotiation
- All commercial UK template agreements will include the new financial appendix
- The financial appendix is mandated for use, unmodified
- The IRAS and interactive costing tool (iCT) submissions will be made in parallel
- 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.
Which studies are in scope of NCVR Stage Two?
During Stage Two the resource review process via submission of iCT remains applicable to all commercial contract research in the NHS.
However, exceptions to the mandatory acceptance of review generated prices at participating sites are:
- Phase I-IIa studies
- Advanced therapy medicinal product (ATMP) studies
- Primary Care studies
Work is underway to bring these studies into the full NCVR process as soon as possible and HSC/NHS organisations are strongly encouraged to accept the outcome and iCT generated prices for these studies.
Sponsor Requirements
- Submit your iCT for study resource review at the same time as your IRAS submission
- 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.
- Copy the iCT finance schedule, when available, into the financial appendix of the agreement to share with participating sites
- 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:
- New functionality, including tiered R&D set up, coordination and close down fees and revised time-based calculations, replacing some unit costs.
- Investigations will uplift based on price variation and outsourcing analysis, with changes visible in the iCT tariff workbook
- 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.