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 and 1 April 2023

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.

As of 1 April 2023, NIHR has replaced the Microsoft Excel version of the SoECAT with an online tool.  NIHR guidance is as follows:

Please be aware that if your planned project includes the recruitment of participants, your application should be accompanied with the Funder Export from the online SoECAT, obtainable via the NIHR Central Portfolio Management System (CPMS).

In order to create a SoECAT, you will need to create an account in CPMS. After creating the account, you will need to login to CPMS to activate this account. If any assistance is required in creating the account, please refer to our user guide. Once your account has been created and is active, you can proceed.

Guidance for the completion of the SoECAT by the applicant is present in the online tool to assist at each page and stage of the application process and further details can be found on the Online SoECAT Guidance page. There is also an Online SoECAT Guidance Module which includes video tutorials and linked resources (an NIHR Learn account is required to access and enrol onto the module) and a helpful Study Representative - Online SoECAT Top Tips infographic.

Please note that completion of the SoECAT may not be necessary when applying for funding to support: overarching programmes with no specific research study protocol, infrastructure, fellowships, anything where the grant is to be used for direct employment of a member of staff or purchase of an asset, and data or diagnostic reviews where recruitment data is not collected. Such applications should be submitted with supporting documentation to explain why a SoECAT was not submitted in this instance.

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 see NIHR guidance via above links.

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.