National contract value review – operational details

This page contains operational and other detailed information needed to implement the national contract value review (NCVR) programme. It is aimed at an audience that is familiar with commercial clinical research costing and contracting and should be read alongside the high level information on the process.

Background

Work on the NCVR process began in 2018/19 with the aim of bringing together two key elements to improve commercial contract research study set up:

  1. The use of an unmodified model site agreement and standard costing methodology, including the use of the interactive costing tool (iCT) has been mandated since October 2018.
  2. The introduction of a national coordinator role (now referred to as contract value review coordinator) responsible for completing the NCVR for the study, ensuring that NHS providers achieve full cost recovery associated with delivering a commercial research study.

While the use of the unmodified site agreement and iCT continued during the pandemic, the introduction of the National Contract Review and role of the previously titled national coordinator role was paused. Following a review and incorporation of learnings to date, the overall NCVR process has been revised and is now being re-introduced.

The national directive has been updated

The NCVR is underpinned by the National standard contract  and the National directive on commercial research studies. After a period of review the National Directive has been updated to reflect the revised process and incorporates the following additions:

  1. A single national price list to facilitate study costing, with NHS organisations required to confirm either that they adhere in full to the costing tool price, or to provide up-front information on price variations and details of what this variation means for commercial sponsors. This price list will be based upon the data collected for the National Institute for Health and Care Research (NIHR) Clinical Research network (CRN) interactive costing tool (iCT): getting started. This information will be available to commercial companies to inform their selection of NHS organisations to take participate in the study.
  2. On a study by study basis, a single negotiation of the resources required to deliver that study in the NHS will be undertaken by a contract value review coordinator on behalf of all participating organisations. The outcome of this negotiation being the application of the costing tool price calculations, with any site-specific variations, and the local execution of the contract, with no subsequent price negotiation by participating organisations.

Stage one of national contract value review implementation

The national directive requirements are being introduced in a staged way, to ensure sites and sponsor companies have time to implement the changes and that lessons can be learnt from early implementation. Taking on board learning from the pre-COVID NCVR process, stage one of implementation will:

  1. Focus on Acute, Specialist and Mental Health Trusts in England and counterparts in the Devolved Administrations and exclude primary care organisations, as well as phase I,IIa, and Advanced Therapy Medicinal Product (ATMP) studies;
  2. Provide commercial sponsors with information on whether individual NHS Organisations will adhere to the local prices generated by iCT methodology in England, to inform selection of sites and Chief Investigators;
  3. Identify an NHS costing expert based at, or working on behalf of, the Chief Investigator as the contract value review coordinator. The contract value review coordinator and sponsor company or Clinical Research Organisation (CRO) will work in partnership to carry out the study resource review and agree on the national iCT activities. Once finalised, the participating organisation-specific prices are generated by the iCT that includes indirect costs, a capacity building element and local Market Forces Factor.
  4. For NHS organisations that adhere to the local prices generated by iCT methodology, the prices are pulled through into local contracts and no local re-negotiation will take place:
    1. There will be an escalation route via the Local CRN or devolved administration support team if there are any concerns relating to costing. Any activities not covered by the iCT will be negotiated locally and raised for inclusion in the next update of the iCT. (overseen by the existing Commercial Costing Reference Group).
    2. In some NHS Organisations there may be justifiable reasons why a local price for an activity is different from      the price generated by the iCT and so they will not adhere to local prices generated by iCT methodology. In these cases the iCT is released and the Participating Organisation input variations from iCT generated prices.

From 1 October 2022 all new commercial research proposals submitted for a study resource review will undergo a review by the lead site. Following this review eligible studies will enter into the NCVR process.

Eligible studies are all those commercial studies which will be conducted in acute, specialist and mental health trusts in England and counterparts in the devolved administrations, with the exception of phase I – IIa and advanced therapy medicinal product (ATMP) studies. Primary Care settings are not included at this stage.

In support of this next stage:

  1. Information has been collated on which NHS Organisations will adhere to the local prices generated by the iCT, and
  2. NHS based costing experts have been identified across the UK to act as contract value review coordinators. See sections below for details.

National contract value review is a UK wide programme

The NCVR programme is being introduced across the UK, while the processes will be aligned, there will be some differences to how the programme will be introduced in the Devolved Administrations to take account of operationalisation in each nation. England specific delivery includes:

  • In England, NCVR is underpinned by the National Standard Contract and the National Directive on Commercial Research Studies, the latter has been revised to take into account the new process.
  • NHS England has commissioned North of England Commissioning Support Unit (NECS CSU) to gather data that identifies those Acute, Specialist and Mental Health Trusts that will adhere to their local prices as generated by the Standard Costing methodology, and those that do not. NECS CSU have collated this information which will be available to companies setting up research through the NIHR’s ‘iCT Getting Started’ webpage for England.
  • NIHR’s Clinical Research Network (CRN) and Devolved Administration support teams will identify, train, and manage contract value review coordinator assignment to new commercial research studies. In the first stage CRN and Devolved Administration support teams will utilise their network structure to ensure R&D staff at NHS organisations are briefed on the proposed approach for identification and training of contract value review coordinators under the new arrangements.

For further information on devolved administrations NCVR delivery see:

There will be reciprocal recognition of Contract Value Reviews conducted by NHS organisations across the UK.

Identification and training of contract value review coordinators

Contract value review coordinators will be an identified cohort of trained individuals, experienced in commercial cost evaluation and based within NHS research and development departments or equivalent research support function. They will work with the study sponsor and chief investigator, to undertake an ‘contract value review’, prior to a company sharing iCT with agreed activities with all other sites.

NHS Organisations do not have to have an ‘in-house’ contract value review coordinator. Wherever possible contract value review coordinators will be located in the NHS organisation where the chief investigator is based.

Comprehensive engagement for research and development staff and other stakeholders to support the rollout of this next phase of the programme is underway. This includes a “community of practice” that will facilitate continuous learning and development.

Comparison of stage one of NCVR implementation with current costing process

Stage 1 of NCVR – Implementation steps Change from current process
Commercial companies will be able to see declaration of adherence to the costs generated by the standard costing methodology for each NHS organisation. This will inform site identification. Provides system wide intelligence – Currently sponsors only find out if individual sites adhere to iCT generated costs when the site has been selected and negotiations are underway.
A commercial company will complete and iterate the iCT to reflect the study requirements outlined in the study documentation and information to be submitted for approval. National resources and Local CRN/devolved administration support based on the location of the lead site is available as necessary for using the tool. No change.
Submission of the iCT for Study Resource Review will enable identification of  a contract value review coordinator relevant to the study. Combines Local CRN validation (quality check for all protocol items listed) with a site level review.
The contract value review coordinator and commercial representative will work in partnership to undertake a national review to confirm the study requirements in the iCT are reflective of the study to be submitted for approvals. The allocated contract value review coordinator will work with the relevant NHS staff, such as the chief investigator, study team or allied professionals (for example pharmacy or radiology), and the commercial representative to ensure the iCT reflects the NHS resource requirements to undertake all the activities contained within the study protocol and supporting study documentation that will form the approval submission. This approach expands scope of chief investigator site responsibilities i.e. ensure resource is appropriately defined to enable delivery of study.
Once the study level iCT has been agreed, the participating organisation-specific versions will be created to embed in the model agreement for each. Site specific versions created following NCVR, rather than after CRN validation.
The finance schedule in the relevant model agreement for each NHS organisation participating in the study will reflect the finalised study values in the iCT and any NHS organisation-specific price as relevant, in line with the declaration. No change.
Where organisations have declared adherence to the costs generated by the Standard Costing Methodology, there will be no local re-negotiation on price or activity. There is an escalation process via the Local CRN or Devolved Administration Support team in the event of a Participating NHS Organisation having concern that there is an error in the iCT. Emerging concerns will be captured to refine the operational process for the contract value review.Where organisations have declared adherence to the costs generated by the Standard Costing Methodology, there will be no local site re-negotiation on price or activity. There will be an escalation process in the event of  a site having concern that there is an error in the iCT. Emerging concerns will be captured to refine the operational process for the contract value review. Defined escalation for working outside national directive.
Participating Organisation adjustments for inclusion of activities dependent on-site type or local delivery mechanisms (e.g. use of clinical research facility) will be reflected in the iCT agreed between the sponsor and that individual participating organisation. No change.
The study model agreement and finance schedule will be signed by NHS organisations in England or Wales when local capacity and capability can be confirmed, subsequent to the conclusion of the NCVR  contract review process. No change.
Executing the model agreement is confirmation of the site specific costs:

  • Protocol amendments impacting costs are reflected at site level
  • An escalation process (to act as a dispute resolution pathway) is defined for use as required by the NHS or commercial sponsor.
 No change.

For enquiries please contact the research team at NHS England here: england.research@nhs.net