Excess Treatment Costs and the Schedule of Events Cost Attribution Template (SoECAT)
Clinical Research: What you need to know and do from 1 October 2018
Excess Treatment Costs (ETCs) occur when treatment costs (the patient care costs) in a research study are greater than in routine care. For example, a patient taking part in research may be given a new drug to see how it performs in comparison with the standard drug given to the non-research patients. If the cost of the new drug being tested in the study is more than the one usually prescribed, then it is an ‘excess treatment cost’, as it would not occur in standard care. For non-commercial research studies, these costs are the responsibility of the NHS.
NHS England, with the National Institute for Health Research (NIHR) and Health Research Authority (HRA), want to improve the management of these costs and thereby, through a more rapid, consistent and standardised approach, cut delays, maximise patient recruitment and make administration simpler than previously. In line with that, NHS England has implemented a new national ETC process, which is being trialled from 1 October 2018 to be rolled out in full by April 2019. These six months will provide time to test and make changes if necessary.
The 15 NIHR Local Clinical Research Networks (LCRNs) will help manage the ETC process on behalf of their local Clinical Commissioning Groups (CCGs) and in collaboration with NHS England’s Specialised Commissioning function. This will create a single point of access for all proposals for which ETCs may be applicable and is designed to make the process simpler for researchers to navigate.
As part of this process, researchers will be required to complete a SoECAT* for clinical research. This form is designed to capture the different costs associated with clinical research and attribute them accordingly. This applies to all full-stage clinical research applications that will be undertaken in England. It does not apply to outline applications. The completed form must be signed off by an AcoRD Specialist‡, to ensure HRA approval and NIHR portfolio status are achieved.
Schedule of Events Cost Attribution Template (SoECAT)
Researchers applying for clinical research grants need to complete a SoECAT to be eligible for the NIHR portfolio and the support this provides.
This is a spreadsheet tool that calculates the different activities and costs associated with clinical research in a standardised way.
You must submit a completed SoECAT with your grant application:
- if you are applying for funding for clinical research
- if you will carry out your research in England
- if your research requires HRA approval
- if your research will use NHS England resources
- even if you don't think your clinical research will involve any ETCs.
Further guidance on completing the SoECAT.
Find out more about the new system, including links to:
- Schedule of Events Cost Attribution Template
- Researcher routemap
- AMRC’s helpful FAQs on Excess Treatment Costs
- An animation by NIHR about ETCs
Under the new system, the SoECAT must be endorsed by an AcoRD Specialist who will confirm that the attribution is accurate. Local AcoRD Specialists work with researchers to signpost them to resources and training to help understand the principles of AcoRD, provide specialist advice and support for activity attribution and give assistance to resolve any attribution queries.
Researchers are urged to engage with AcoRD Specialists as early as possible and provide as much notice as possible that support will be required. This is essential in order to submit the full application, together with the completed, endorsed SoECAT, by the application deadline, and also to ensure HRA approval and NIHR portfolio status are achieved.
Applying to Kidney Research UK
If you are applying for funding from Kidney Research UK to carry out clinical research in the NHS, you will need to factor in the time to complete a SoECAT and have an AcoRD Specialist sign it so that you can upload and include it as part of your online application submission.
Please be aware that the research award does not include NHS Support and/or Treatment Costs. NHS Support Costs will be funded via the Clinical Research Networks. NHS Treatment Costs, including any Excess Treatment Costs/Savings, will be met by the NHS through normal patient care commissioning arrangements. Such costs should not be included in your application's budget.