Faster costing and contracting
A new, standardised, national approach to costing and contracting for commercial contract research is being introduced across NHS sites in England to improve consistency and reduce unnecessary delays to study set-up.
Life science organisations and Contract Research Organisations (CROs) choosing to conduct clinical research in our NHS will experience quicker and easier multi-site study set-up:
- Less time negotiating costs and contracts with multiple sites
- More consistency when defining resource and procedure requirements across the country
- Better transparency in how resource requirement is costed across the country
- Better predictability of the overall costs to deliver a multi site study
- Reduced administration requirements
Model site agreements
As of 1 October 2018 all NHS sites, life science companies and/or CROs conducting commercial contract clinical research in the NHS are mandated to use an unmodified model site agreement. These are nationally accepted contract terms which, when used without modification, will eliminate delays caused by contract negotiations and legal reviews for each NHS site delivering your study. They are also a required document for acquiring Health Research Authority (HRA) approval (combined governance, legal, ethics approvals).
The suite of model site agreements have been designed for a range of various research scenarios and are supported by guidance documents.
Standard costing methodology (Costing Tool/Template)
As of 1 October 2018 all NHS sites in England conducting commercial contract clinical research are also mandated to use the NIHR standard costing methodology when contracting with life science companies and/or CROs. The standard methodology provides a framework for transparent cost display and calculation to support swift local site budget negotiations. This means less variation when defining resource requirements across the country, better transparency in how that resource requirement is costed locally, and better predictability of overall study delivery costs. Currently the standard commercial contract research costing methodology is available in two formats:
interactive Costing Tool (iCT)
This is a new digital (web-based) version of the Excel Industry Costing Templates (see below). You will need to create an NIHR Central Portfolio Management System (CPMS) account to use the interactive Costing Tool (follow the link and click on ‘create an account’). There are a range of information resources available, including video tutorials, to help you use the iCT. To find out more and access the iCT read the guidance:
- The interactive Costing Tool (iCT): Getting started.
- Alternatively you can access our Early Contact and Engagement Service for further advice.
Excel Industry Costing Template
There are only two Excel Industry Costing Templates (Primary and Secondary Care) available for download. To find out more and access the templates read the guidance:
- The Excel Industry Costing Template: Getting started.
- Alternatively access our Early Contact and Engagement Service for further advice.
How to get your study costing validated
The Local Clinical Research Network (LCRN) leading on the study (usually where the Chief Investigator site is located) will perform a quick ‘quality check’ or validation of the study specific costing. This validation is required prior to HRA Approval and an application for the NIHR Clinical Research Network Portfolio is required before the validation can take place.
The validation ensures that all protocol required procedures, investigations and tasks are included in the template and highlights areas where additional activities may be required for inclusion to capture all the requirements for the site. The validation does not consider the price, time value or standard of care status for any study activities as this currently remains the responsibility of each participating organisation to consider during local capacity and capability activities. See what checks are included in the validation. The final stage is gaining cost approval from each individual NHS organisation.
How to include the study costings in the contract
Suggested content for the Financial Appendix (Word document) of the model site agreements has been developed to support the inclusion of the study specific costing into the contract. This document is also included as a direct output of the new iCT.
How to update the costs in the contract
The NIHR Clinical Research Network Costing Group has developed suggested content for a change order template (Word document) for the model site agreement. Understand what income distribution could look like in your NHS organisation by reading the NIHR Clinical Research Network Income Distribution Model.
Single contract review process
The next phase of improvements led by NHS England and NHS Improvement will be implemented during 2019 and will introduce the concept of a single contract review process. This is a nationally coordinated contract value negotiation process. It will ensure a fair, transparent and consistent approach to research costing across the country and reduce the need for resource allocation negotiation, focusing negotiations at individual sites only on specific local requirements.
In the next phase of implementation, a national coordinator will be assigned to each commercial contract study to negotiate the resource and procedure allocation required to deliver the study. Once the company has accepted the allocation it will be ‘validated’ and will be issued to all participating sites for local costing using the mandated national costing methodology (the NIHR costing tool or template). Additional resource requests from participating sites can be submitted but the sponsor company will be able to ask for a justification for the request, and an audit trail for these requests will be generated.
A number of NHS sites that are experienced in commercial research are currently testing the proposed process for a single contract review. This will enable an analysis of the impact of the process. Sign up to receive our newsletter to stay up to date on these developments.
The NHS England and NHS Improvement National Directive on Commercial Contract Research Studies
These changes are being implemented in response to the feedback from life sciences industry partners which was acquired through the NHS England and NHS Improvement consultation on Supporting Research in the NHS. Following the consultation, on 1 October 2018 a National Directive on Commercial Contract Research Studies came into force setting out the requirements that NHS service providers need to adhere to when delivering commercial contract research. Development and implementation of the directive has been led by NHS England and NHS Improvement in partnership with NIHR and HRA.
Working across the UK
Although the single contract review process approach is being led by NHS England and NHS Improvement, the costing and contracting tools, models and associated template agreements are accessible throughout the UK, including Northern Ireland, Wales, and Scotland. Once fully implemented, a streamlined approach to a UK wide contract review process will be piloted. Ongoing projects are in place to continue to bring together all devolved administrations to enable a smoother and quicker start up process.
If you didn't find what you were looking for or if have any questions or comments please contact the Study Support Service Helpdesk:
- 📧 email@example.com
- ☎ 0113 343 4555
If your study is already part of the NIHR Clinical Research Network Portfolio and you need support or help with a specific site please contact your local Industry Operations Manager for support.
- Model Site Agreements and guidance
- The interactive Costing Tool (iCT): Getting started
- The Excel Industry Costing Template: Getting started
- List of industry costing template validation checks for companies
- Suggested content for the Financial Appendix of the model site agreement
- Suggested content for a change order template for the model site agreement
- NIHR Clinical Research Network Income Distribution Model
- What the NHS National Directive on Commercial Contract Research Studies means for the Life Sciences Sector
- Timeline of Commercial Contract Research Set-up Improvements
- Eligibility criteria for NIHR Clinical Research Network support for commercial studies
- User guide for the NIHR study Support Service: Industry Route Map
- NHS England and NHS Improvement: National Directive on Commercial Contract Research Studies
- NHS England and NHS Improvement: 12 Actions to Support and Apply Research in the NHS
- IRAS Help: Contracts and study agreements
- HRA: Model site agreements
- NIHR Study Support Service: Industry Route Map
- Animation: An introduction to the Study Support Service: Industry Route Map (2 minutes)
- Animation: The NIHR Study Support Service (2 minutes 30 seconds)