National Contract Value Review
The way commercial research is costed and negotiated in Scotland and across the UK has changed, improving consistency and reducing unnecessary delays to study set up through a process known as National Contract Value Review (NCVR).
What is NCVR?
NCVR is a standardised, UK-wide approach to costing for commercial contract research studies. It provides a standard agreed approach to assessing the resources and the price needed to deliver commercial research studies within NHS organisations. This work forms part of a broader common goal to ensure clinical research continues to thrive in the UK, for the benefit of patients and the public.
Stage One of NCVR was implemented from the 1 October 2022. In the first six months of NCVR, over 200 studies completed the NCVR study resource review. The average time to complete the study resource review phase was only 29 days, as a result of which the time taken to go from costing submission to first patient recruitment was reduced by 45% (from an average of 213 days to 118 days). On average 10 UK NHS research sites took part in each study. NCVR has not only helped to deliver faster site set up but has also freed up resource in sites to carry out other research activity.
- 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 iCT submissions will be made at the same time
- Study resource reviews will be managed under stage two principles
- iCT national review is shared with applicant rather than site. The applicant copies the organisation-specific iCT finance schedule into the new template contract appendix, to be shared with site. Sites will still receive the full organisation-level budget detail from the iCT, to support invoicing and internal disbursement, as sponsors will provide this
- 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
- Copy the iCT finance schedule, when available, into the financial appendix of the agreement to share with 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 Scotland remains the same
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.
Any agreement not exchanged (signed by both parties and notified / returned to the sponsor) will need to follow NCVR Stage Two from 18 October 2023. This means that any studies in set up with unsigned contracts will need to use the revised contract template, with new financial appendix and iCT generated finance schedule. For sites where contract exchange has not happened before 18 October 2023, the iCT generated budget will apply without local negotiation.
Which studies are in scope of NCVR Stage Ttwo?
During Stage Two the full NCVR process (lead NHS site review and iCT outcome acceptance) remains applicable to all commercial contract research in the NHS.
The only exceptions are:
- Phase I-IIa studies
- Advanced therapy medicinal product (ATMP) studies
Work is underway to bring these studies into the full NCVR process as soon as possible.
For any studies (both included and excluded) taking place within independent contractor / Primary Care sites, these sites do not have to accept the iCT outcome. A voluntary adherence scheme is currently being implemented to bring more research settings into the full NCVR process.
For specific queries please contact Ewan Dougall, NRS Commercial Manager - email@example.com