National Contract Value Review
New programme making it easier and faster for study set up and delivery in Northern Ireland
The National Contract Value Review (NCVR) is the UK’s standardised, national approach to costing and contracting for commercial contract research, and was first introduced on 1 October 2022 through a UK staged approach for eligible studies. In Northern Ireland, NCVR is being delivered by the HSC Research Approvals Service in partnership with the HSC Trust organisations and Sponsors.
NCVR is a method to agree the resources and price needed to set up commercial research studies taking place in the National Health Service/Health & Social Care (NHS/HSC) within the UK. The aim being to improve consistency and to make it easier and faster for study set up and delivery. The NCVR programme of 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, outlined in Lord O’Shaughnessy’s review recommendations.
The NCVR process builds on what has been achieved with the UK commercial Costing Template (NIHR interactive Costing Tool - iCT) to create a single contract value review with an assigned National Resource Reviewer for each commercial contract study taking place in the UK. There is reciprocal recognition of contract value reviews conducted by NHS/HSC organisations across the UK and an escalation process agreed for queries and variance from standard procedures as this new programme rolls out.
Early impact of NCVR Stage One
Within the last 12 months, over 600 studies have had a national review completed and over 60 have gone all the way through the set up process. This means they have had a national study resource review conducted, opened to recruitment at participating sites, and participants have been enrolled in the study. An analysis of these 60+ studies confirms that:
· Set up times are over 100 days quicker and as much as 185 days quicker when compared to the pre-pandemic data for 2019/20.
· When compared to the 12 months prior, the average time from initial costing submission to the date of the first participant consenting to participate in the study, has reduced from 305 days to 194 days; a reduction of 111 days or 36%.
Analysis of the data will continue as more studies complete the NCVR process.
NCVR Stage Two
During October 2023 some aspects of NCVR will change as it enters stage two:
All commercial studies are submitted through the interactive costing tool (iCT) from 1st October 2023:
· there is no local NHS/HSC site price negotiation;
· the new UK template agreement for commercial studies 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 study resource review is shared with applicant/sponsor rather than site. The applicant/sponsor 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.
As a sponsor, what I need to do from 1 October 2023?
From 1st 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 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.
What is changing from 18th October 2023?
The interactive Costing Tool (iCT) has been 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;
· for England only, site multipliers are being 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. The Market Force Factor for Scotland remains the same, with Wales and Northern Ireland having been recently revised and uplifted.
Please note that items such as participant travel, subsistence allowance and archiving costs, where required, 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 any costs incurred over the cap requiring sponsor authorisation.
What does this mean for sites currently in set up from 18 October 2023?
Any agreement not exchanged (signed by both parties and notified / returned to the sponsor) can be discussed between site and sponsor for best resolution.
What does this mean for sites currently in set up from 18 October 2023?
During stage two the full NCVR process (national resource review completion) remains applicable to all commercial contract research in the NHS/HSC.
The only exceptions are:
· Phase I-IIa studies.
· Advanced therapy medicinal product (ATMP) studies.
Work is currently underway to bring these studies into the full NCVR process. In the meantime these types of studies continue to submit their study for National Review using the ICT, however costs may change during site negotiations.
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 being implemented to bring more research settings into the full NCVR process through a voluntary sign up scheme has been developed whereby general practices agree to accept the prices generated by the iCT to develop the evidence and support the wider roll out of NCVR in primary care.
Where can I get more information and support with the NCVR process?
There are a number of useful UK NCVR resources available on the NIHR website including a getting started guide Guidance: Using the interactive Costing Tool (iCT) | NIHR
For more information and support please email the team at ncvr@hscni.net
While processes will be aligned across England, Scotland and Wales there are some slight differences within each nation to how the programme is being implemented. More information can be found on each nation’s website:
What is the site escalation process for NCVR?
There is an NCVR escalation pathway to understand when and how to escalate issues or errors with the NCVR review, or wider NCVR programme. An infogram has been co-created by the four UK nations which provides information on the UK NCVR escalation pathway. Escalations are managed by a nation-specific ‘one point of contact’ approach to prevent reviewers being contacted by multiple sites and to ensure learning can be captured. For Northern Ireland, this is being managed by the HSC Research Approvals team who can be contacted at ncvr@hscni.net
Resource Links:
Supporting guidance has been produced to support the various stakeholders in the NCVR process, and include infographics, FAQs and video tutorials User resources for the interactive Costing Tool and the role of iCT in supporting NCVR
For local participating site and sponsor/applicant queries on NCVR involving Northern Ireland as the lead nation, please contact ncvr@hscni.net
Press release 26 October – Commercial study set up times reduced by a third, according to new data: https://www.nihr.ac.uk/news/commercial-study-set-up-times-reduced-by-a-third-according-to-new-data/34693