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From Sunday 1 October, as part of work to improve the set-up of commercial studies in the UK, some aspects of National Contract Value Review (NCVR) are changing.
In response to Lord O’Shaughnessy’s independent review of commercial clinical trials, the government committed to the addition of an unmodifiable financial appendix to the suite of UK template commercial agreements. This, and other changes in NCVR stage two, will remove local contract and contract-value negotiation and improve study set up.
What is changing with NCVR stage two on 1 October 2023?
For all studies submitted in IRAS or interactive costing tool (iCT) from Sunday 1 October 2023:
- 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)
- there is no local site budget negotiation. Site budget set by site multiplier (Market Force Factor or MFF).
Which studies are in scope of NCVR stage two?
All commercial contract research to take place in the NHS across the UK is planned to be in scope of NCVR. There are some exceptions for stage two: phase I-IIa, advanced therapy medicinal product (ATMP) studies and studies carried out in independent contractor primary care.
We plan to include the studies excluded from stage two in the NCVR process as soon as possible.
As a sponsor what do I need to do from 1 October 2023?
From Sunday 1 October 2023 you must:
- 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 1 October
- when available, copy the iCT finance schedule 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
What is changing on 18 October 2023?
The iCT will be updated to include:
- 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
- site multipliers to smooth out delivery variations across England are incorporated through a revised Market Force Factor value for research. This change applies at the point of creating site specific versions and will be visible in the iCT tariff workbook
- items such a 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.
NIHR is currently updating the iCT user guide and NCVR resources to reflect stage two.
What does this mean for sites currently in set up from 18 October 2023?
Any agreement not exchanged (signed by both parties and notified or 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.
Your feedback is important
Thepage for iCT and local costing on the NIHR's website tells you how to escalate any issues with NCVR.
You can find out how to share feedback on the contracts or finance appendix in IRAS Help.
In July, we shared the draft finance appendix and revised contract agreement for comments. We received over 800 comments from over 80 organisations, and each was reviewed and considered by the UK Four Nations Contracting Leads Group. We’re very grateful to everyone who took the time to give us feedback.
All contracts are reviewed every six months and updated as needed, based on feedback. Please do continue to tell us what you think.
Call to action
Research and development managers at participating sites please ensure that you cascade this information across your organisation to all those you may be currently involved in costings or contracts.
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