Costing a clinical study

Here we give an overview of the costs you should consider when applying for funding for a clinical study.

Before you complete your application

Before completing an application to us for a clinical study, you must consult with all relevant parties to identify how the costs of the study will be resourced and how governance will be handled.

Relevant parties will usually include:

• The finance office in the institution where the principal investigator is based.
• The Research and Development (R&D) office in the NHS Trust(s) where the study will be led.
• In England, the lead National Institute for Health and Care Research (NIHR) Clinical Research Network (CRN) responsible for providing infrastructure for the study, the Chief Scientist Office (CSO) in Scotland, the National Institute for Social Care and Health Research (NISCHR) in Wales, or the Health and Social Care (HSC) R&D office in Northern Ireland.
• An NIHR AcoRD specialist to review and sign off the Schedule of Events Cost Attribution Template (SoECAT) form, which is used to attribute the different costs associated with clinical research. 

The Department of Health and Social Care (DHSC) has published guidance, known as AcoRD guidance, for attributing the costs of clinical studies. This guidance clarifies the distinction between Research Costs Part A (payable by funders), Research Costs Part B (met by the DHSC), NHS Support Costs and NHS Treatment Costs. The guidance also provides a set of examples and Frequently Asked Questions. You should refer to these documents and to our guidance below when costing your clinical study. 

The costs of a clinical study fall into three categories

Research Costs

These are the costs of the research itself. They include the costs of data collection and analysis and other activities that are undertaken specifically to answer the research questions.

In general, we are prepared to pay the full direct costs of the clinical research, including salaries of staff employed to carry out the research and consumable costs associated with the research.

However, as with other medical research charities, we expect universities and the NIHR (or its equivalents) to provide the infrastructure enabling the research to be carried out, and in general we will not pay indirect costs of research or directly allocated costs (e.g. fractional salaries of staff who already have academic PAs in their contracts). We will also not take on the role of a sponsor in a clinical study, and will not expect to pay Research Costs, Part B as defined by the AcoRD guidance).

Examples of research costs that we will not expect to pay, and which need to be discussed with and attributed to either the university or the NIHR (or its equivalents), include:

• Sponsorship fees and insurance.
• Regulatory preparation and compliance work.
• R&D support for processing research approvals.
• PAs for tenured active clinical investigators.
• Posts for support services (for example pharmacy or radiology).
• Local study co-ordination and management costs outside the lead centre (the centre where the principal investigator is based).
• Data collection where the activity is undertaken by existing staff employed by the NHS, NIHR Research Delivery Network (NIHR RDN) or other organisations funded by the NHS to provide patient care services.

NHS Support Costs

These are the additional patient care costs associated with the research that would end once the research has stopped, even if the treatment, device or diagnostic test being studied continues to be provided.

NHS Support Costs include the costs of identifying patients who may be suitable to approach for participation in the study, obtaining informed consent, extra patient tests, extra nursing attention or extra in-patient days required to monitor the patient’s condition to ensure their safety during the study.

NHS Support Costs are met from the R&D budget of the Health Departments of the UK. You must discuss the provision of NHS support for your study with the lead NIHR RDN in England, the CSO in Scotland, the NISCHR in Wales, or the HSC R&D office in Northern Ireland.

Find out more information about accessing support from the NIHR RDN.

NHS Treatment Costs

These are the patient care costs that would continue to be incurred if the treatment, device or diagnostic test continued to be provided after the end of the study.

Excess Treatment Costs (ETCs) are the difference between the costs of the treatment being studied and that of the standard treatment.

NHS Treatment Costs include the costs of:

• Supplying and administering the medicine/device/therapy being studied.
• Supplying and administering any active comparators (but not placebos or sham treatments).
• Training of staff to deliver the treatment.

Please read our guidance about claiming Excess Treatment Costs. 

The SoECAT form

Researchers applying for HRA approval for clinical research studies taking place in England need to complete a form known as a Schedule of Events Cost Attribution Template (SoECAT). The SoECAT is a spreadsheet that attributes the different activities and costs associated with clinical research in a standardised way.

Please note that the SoECAT form should be used for attribution of cost type only (Research Part A, Research Part B, Support Costs or Excess Treatment Costs), but is not a costing tool, and should not be used to calculate the amount of funding requested for Research Part A costs.

You can find guidance on how to complete the SoECAT on the Online SoECAT Guidance page. There is also a Study Representative - Online SoECAT Top Tips infographic.

Sign off by an AcoRD specialist

As part of your funding application to BHF, researchers (usually the Chief Investigator or their study team) are required to complete the SoECAT. You must send your completed SoECAT to your NIHR Regional Research Delivery Network (RRDN) AcoRD specialist to be authorised. To get in touch with an AcoRD specialist, contact the Lead CRN for the study (meaning the LCRN that takes overall responsibility for the study within the NIHR RDN — usually determined by the region where the Chief Investigator/lead site is based).

For the funding application to be valid, the AcoRD specialist must approve and sign off the final completed SoECAT, confirming that the attribution of costs is accurate, prior to you submitting the application to BHF. The AcoRD specialist must also sign off the SoECAT as a prerequisite for the study to be eligible for the NIHR Research Delivery Network Portfolio and to access the support portfolio adoption provides.

You should engage with an AcoRD specialist as early as possible and provide as much notice as possible that support will be required. 

The minimum time required to ensure sign off by the submission date is 20 working days before the submission of a funding application.

Please allow at least 10 working days for authorisation of a SoECAT by an AcoRD specialist.

If you are submitting a full application to the BHF for a Clinical Study Grant to support a study taking place in England, you will need to submit the signed-off SoECAT to the BHF as part of your online application on the Grants Management System.