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Schedule of Events Cost Attribution Template (SoECAT) guidance

Published

28 November 2019

Version

V2.0 / December 2019

Contents

Introduction

The Schedule of Events Cost Attribution Template (SoECAT) has been developed and implemented across the United Kingdom by a partnership of organisations, including the Department of Health and Social Care (DHSC); NHS England and NHS Improvement (NHS E/I); Health Research Authority (HRA); NIHR Clinical Research Network (CRN); the devolved administrations (NHS Research Scotland, Health and Care Research Wales, Northern Ireland Public Health Agency); NHS Research and Development Forum; research funders and research active NHS organisations.  

Unless otherwise stated, the guidance in this document applies across the UK.  Nation specific variations are detailed in Appendix 1.

SoECAT is maintained by the UK SoECAT Steering Group and suggestions for improvement and other feedback may be directed to phillip.good@nihr.ac.uk

Although SoECAT is currently an Excel file, the aim is to move towards an on-line version.

SoECAT templates

Schedule of Events Cost Attribution Template A (SoECAT)
Schedule of Events Cost Attribution Template B (SoECAT)

The purpose of SoECAT

SoECAT is a tool for use with non-commercial research studies in the four UK nations.  Its primary purpose is to ensure that site-level costs (*1) are appropriately attributed according to AcoRD (*2) principles at the time of application for research funding and hence to ensure that site level Research Costs are met via that funding, but it also has several other roles and functions:

  • SoECAT functions as a cost attribution template but is not intended primarily as a study costing tool.
  • If completed at the research funding application stage, it should also form part of the IRAS application document set (in place of the IRAS Schedule of Events) where the research is to take place in or through the NHS or Health and Social Care (HSC);
  • If submitted in IRAS, as above, it should form part of the UK Local Information Pack, that the sponsor or their authorised delegate shares with participating NHS/HSC organisations to support the arranging of local capacity and capability (England, Northern Ireland and/or Wales) or the issuing of NHS Management Permission (Scotland);
  • It provides the Excess Treatment Cost (ETC) per participant value, which in some UK nations informs ETC processes as per Appendix 1.

In forming part of the submission package for research funding and, where this is the case, replacing the IRAS Schedule of Events in the IRAS submission and UK Local Information Pack, the SoECAT introduces greater consistency and streamlining across the funding, planning and site set-up stages of a project.

Footnotes:

(*1) By ‘site-level’ we refer to activities associated with the delivery of the research at site, i.e. excluding activities relating to study design and/or management, which we refer to as ‘sponsor-level’ and are outside of the scope of SoECAT

(*2) Attributing the costs of health and social care Research and Development - which provides a framework for the NHS and its partners to identify, recover and attribute the costs of health and social care R&D (AcoRD), in a transparent, and consistent way. It makes clear the distinction between the 3 costs: Research Costs, NHS Support Costs and Treatment Costs and describes how these costs should be met.

SoECAT at Research Funding Application Stage

SoECAT is a cost attribution template designed to support correct cost attribution at application for Research Cost funding, to ensure that full site level Research Costs are recovered. There are activities in addition to the site level activities that in many cases would also need to be included in the application for Research Cost funding (e.g. centrally incurred costs associated with management, monitoring etc.).  SoECAT will not normally reflect all activities that are included within an application for Research Cost funding.

As SoECAT is based on a schedule of events and hence a participant pathway, it does not reflect the usual annual expenditure format of Research Cost funding applications.  It also assumes that every participant will complete their allotted pathway.

The values generated by SoECAT use the baseline costing methodology from the NIHR CRN Industry Costing Template / interactive Costing Tool (iCT) i.e. values before any commercialisation is added. These are average values that have been generated from data submitted by NHS providers and are reviewed on an ongoing basis. As with the Industry Costing Template, it is not expected that a single template value will reflect the exact costs at each NHS commissioned provider/site. 

It would be unusual for the summary figures generated by SoECAT to closely reflect those in the Research Cost funding application or in the final grant or award.  For these and other reasons SoECAT should not be used as a costing tool; other methods should be used to calculate the costs to be included in applications for Research Cost funding.

The SoECAT generates values using a consistent methodology that enables funders to make cost comparisons between similar studies.  The SoECAT generates three values (as defined by AcoRD):

  • The Excess Treatment Cost (ETC) value, which is an indication of the potential overall ETC value of the study. Appendix 1 sets how each of the four UK nations use this information.
  • The NHS Support Cost value, which is an indication of the potential overall NHS Support Costs (or their equivalent in a social care setting) that the study might need.  This value is used to help funders determine the overall value for money of the study and may be used to help inform timing and provision of resources to undertake these support activities. The values generated do not represent the cost value of the NHS Support that will be provided to the study in any UK nation.
  • The site-level Research Cost value, which is unlikely to be the total Research Cost of the study.  This value provides an indication of site-level Research Costs, which are one element of the total Research Costs required to deliver the study.   Funder application forms are designed to include all the Research Costs of the study and activities included in the SoECAT should help inform completion of the funder’s application form (but do not have to be the same, if applicants deem their costs to be different).  

SoECATs must be authorised by an AcoRD Specialist prior to submission for Research Cost funding. The SoECAT thereby helps to ensure that Research Cost funding decisions do not need to be revisited because of activity omissions or incorrect attribution.

When a SoECAT is required

A SoECAT is required by NIHR and NIHR non-commercial partner research funders where the call relates to studies that may involve participants under an NHS or Health and Social Care duty of care. Applicants should follow the instructions of each funder, for that funding call:

  • If your study is funded by a NIHR infrastructure award where the NHS Support Costs are covered but the ETC are not, you will need to complete a SoECAT to access the ETC process for England.

A SoECAT should be completed for the Research Cost funding application for any non-commercial study intended for the NIHR CRN Portfolio, even where the funder is not an NIHR or NIHR Non-Commercial Partner funder (i.e. where an application for adoption of the study to the portfolio will be made).

A SoECAT should be completed for the Research Cost funding application for any non-commercial study eligible for NHS Support Cost (or their equivalent in a social care setting) or Excess Treatment Cost support in Northern Ireland, Scotland or Wales, even where the funder is not an NIHR or NIHR Non-Commercial Partner funder and even where there are no sites in England.

Where a Research Cost funding application has an outline and second stage, the SoECAT should be submitted at the second final stage.

If in any doubt as to the requirement for a SoECAT at Research Cost funding application stage please consult the guidance provided by the research funder, contact the funder to discuss and/or contact your local AcoRD Specialist (in many cases the guidance for the application will be explicit, e.g. for NIHR and NIHR Non-Commercial Partner funders.  In other cases, the funder itself may not require the SoECAT but your local AcoRD Specialist will be able to advise as to whether one should be submitted anyway).

Some funding calls may attract both applications for studies that require SoECAT completion and applications for studies where SoECAT completion is unnecessary. In these circumstances the default position is that the SoECAT should be submitted for all applications, but where completion is not needed this should be indicated on the front sheet of the template and ratified by AcoRD Specialist sign off. Only the front sheet of the SoECAT needs to be completed in these circumstances.  Some funders may determine that applications for a specific call will not require a SoECAT because none of them will require Excess Treatment Cost or NHS Support Cost support (e.g. funding calls for research not involving human participants).  These funders will need to make this clear in the call guidance. 

SoECATs should also be completed for applications for research awards that fund a programme of activity such as NIHR Programme Grants for Applied Research.  Completion should be based on information available at the time of the application.  Due to the nature of programme grant awards, study specific SoECATs may be required once research studies being undertaken as part of the programme grant award have been defined – i.e. at the point of IRAS application. 

Studies that are amended as a result of research funding panel decisions will need their SoECAT updated accordingly, including AcoRD Specialist sign off.

All SoECATs, whether submitted for Research Cost funding or in IRAS, need to first be authorised by a designated AcoRD Specialist from the lead nation. For cross-border studies, a SoECAT will only need to be authorised once and will be accepted where relevant in each UK nation involved in the study.

SoECAT is not used for commercial contract research studies.  There is an interactive costing tool for commercial studies.

SoECAT at IRAS Application Stage

If a SoECAT has been submitted for the Research Cost funding application, it should also form part of the IRAS Form application.

Applicants who have not submitted a SoECAT in application for their Research Funding may continue to submit an IRAS Schedule of Events in their IRAS submission.  Applicants for studies intended for inclusion in one of the UK research network portfolios are however encouraged to discuss this in advance with their Lead local AcoRD Specialist.  The AcoRD Specialist will be able to advise whether completion of a SoECAT will be required to access funding for ETCs.

One SoECAT should be submitted per outline Organisation Information Document.

The activities in each SoECAT should indicate the activities to be undertaken by the organisation with which that Organisation Information Document and SoECAT are to be shared (e.g. activities related to recruitment and treatment should be deleted from the SoECAT intended for the organisations only undertaking follow-up).  Activities not relevant to certain sites should be deleted from a SoECAT without re-authorisation of that SoECAT by an AcoRD Specialist.  Activities should not be added, nor should attribution be modified, subsequent to authorisation by an AcoRD Specialist.  If such modification is required, the SoECAT should be re-authorised prior to IRAS submission.

SoECAT as part of the UK Local Information Pack

Where SoECAT/s has/have been submitted as part of the IRAS application this/these will also form part of the UK Local Information Pack to be shared with participating NHS/HSC organisations.

The UK Local Information Pack should include the SoECAT relevant to the organisation with which it is shared (e.g. organisations only undertaking follow up should be provided with the SoECAT that includes only follow up activities).

Amendments

If an IRAS application consisted of only one outline Organisation Information Document and SoECAT (as would be the case where all participating NHS organisations were expected to be undertaking the same activity) but the sponsor now intends to open organisations undertaking a subset of the overall site-level activities, (e.g. sites are being added that will undertake only follow-up activities) an appropriately modified SoECAT should be provided to the national coordinating function of the lead UK nation as per guidance on non-substantial amendments.  Similarly, if the original submission reflected more than one site type but additional site types are being added, additional SoECAT/s should be submitted in accordance with the amendment process to reflect the new site type/s.  Unless activities are added, or attributions modified, additional AcoRD Specialist authorisation is not required.

Up to two amendments can be made to a study without submitting a revised SoECAT, as long as the changes have no impact on ETCs, but upon a third amendment, excluding amendments to add sites/PICs, a revised and re-authorised SoECAT should be submitted to ensure that the SoECATs maintain alignment with the study.  If the sponsor intends to amend the study in such a way that the ETC activities described in the SoECAT/s submitted in IRAS are changed, a revised and re-authorised SoECAT/s should be submitted with the amendment.

Nation Specific ETC Processes

Although use of the SoECAT in application for Research Cost funding, as well as inclusion in both the IRAS application and the UK Local Information Pack, are common to all four UK nations, there are a number of nation specific differences relevant to SoECAT and these are set out below:

England

For non-commercial studies on the NIHR CRN Portfolio, the ETC figure generated by the SoECAT is used for the NHS E/I and NIHR CRN processes for recognising and recompensing ETCs.  

  • For studies where CCGs are the primary responsible commissioners for funding ETCs. the ETC figure used to recompense providers is the one generated by the SoECAT.
  • For studies where Specialised Commissioning is the primary responsible commissioner, an additional financial assurance process is required for funded applications to determine the net ETC funding that providers will require, to ensure there is no duplication of payments for activity likely to already be chargeable under existing NHS contracts. Specialised Commissioning will provide additional support to the applicant where needed to complete the assurance process.
  • For studies involving services commissioned by other NHS E/I commissioners and for Public Health studies commissioned by Local Authorities, where there is an equivalent excess intervention cost the ETC value will also be used to inform the final agreed value. For guidance on managing ETCs for Research into Public Health Interventions Commissioned by Non-NHS Organisations in England, read the following document: Researcher guidance for public health ETCs 

Northern Ireland

The ETC value may be used in mechanisms for recompensing ETCs in Northern Ireland. Visit the  HSC R&D Division - Northern Ireland website for more information about the process for studies taking place in Northern Ireland.

Scotland

The ETC value may be used in mechanisms for recompensing ETCs in Scotland.  Visit the NHS Research Scotland website for details on the Scottish process.

Wales

The ETC value can be used in Wales, exactly as generated or amended using the Welsh ETC costing template if more appropriate. Visit the Health and Care Research Wales website for more details on the Welsh process.

Completing a SoECAT

Guidance on how to complete the SoECAT is available here.

Glossary of Terms

AcoRD – Attributing the costs of health and social care Research and Development a framework for the NHS and its partners to identify, recover and attribute the costs of health and social care R&D.  AcoRD makes clear the distinction between the three costs: Research Costs, NHS Support Costs and Treatment Costs and describes how these costs should be met.

AcoRD Specialist – The NIHR has established a network of AcoRD specialists to:

  • Signpost researchers to resources and training to understand the principles of AcoRD
  • Provide specialist advice and support for activity attribution
  • Support resolution of attribution queries

CCG – NHS Clinical Commissioning Group. Clinically-led statutory NHS bodies responsible for the planning and commissioning of health care services for their local area.

DHSC - Department of Health and Social Care. A ministerial department responsible for government policy on health and social care matters in England. It oversees the English National Health Service (NHS)

ETC - Excess Treatment Cost - the difference between the Treatment Costs in a research study and the costs of the existing standard treatment.

HRA - Health Research Authority. The HRA protects and promotes the interests of patients and the public in health and social care research.

IRAS – Integrated Research Approval System, a single system for applying for the permissions and approvals for health, social and community care research in the UK.

IRAS SoE – IRAS Schedule of Events

NHS E/I - NHS England and NHS Improvement. NHS E leads the National Health Service (NHS) in England. NHS I supports foundation trusts and NHS trusts to give patients consistently safe, high quality, compassionate care within local health systems that are financially sustainable. NHS E and NHS I came together to act as a single organisation on 1 April 2019.

NIHR CRN - NIHR Clinical Research Network. They support patients, the public and health and care organisations across England to participate in high-quality research. The CRN is comprised of 15 Local Clinical Research Networks (LCRNs) and 30 Specialties who coordinate and support the delivery of high-quality research both by geography and therapy area. National leadership and coordination is provided through the CRN Coordinating Centre.

NIHR CRN Portfolio - All high-quality research studies, eligible for NIHR CRN support in England, are included on the NIHR CRN Portfolio. NIHR CRN supported studies benefit from the following:

  • Access to the NIHR CRN Study Support Service - a standard national framework for supporting the planning, set-up and delivery of high quality clinical research in England
  • Provision of NHS support as defined by AcoRD and/or the equivalent of NHS Support in other settings (e.g. research carried out in social care, care homes, hospices, or public health settings)
  • Provision of Research Part B costs as defined by AcoRD (for studies funded by AMRC member charities only)
  • Access to relevant research delivery training, including Good Clinical Practice training
  • ISRCTN registration via the Central Portfolio Management System. Registration of non-commercial studies with an interventional component is funded by the Department of Health and Social Care

NIHR non-commercial Partners - fund research that is of clear value to the NHS, social care or public health; and take appropriate account of the priorities, needs and realities of the NHS, social care or public health in making decisions about the research that they fund. NIHR non-commercial partners gain benefits including faster access to the full range of services offered by the NIHR Study Support Service which helps researchers to plan, setup and deliver clinical research in England.

PHE - Public Health England

PICs - Patient Identification Centre

Research Costs – the costs of the R&D itself that end when the research ends. They relate to activities that are being undertaken to answer the research questions.

Site-level activities - activities associated with the delivery of the research at site

SoECAT - Schedule of Events Cost Attribution Template

Support Costs – the additional patient care costs associated with the research, which would end once the R&D study in question had stopped, even if the patient care involved continued to be provided.

Treatment Costs – the patient care costs, which would continue to be incurred if the patient care services in question continued to be provided after the R&D study had stopped.

UK Local Information Pack - a consistent package to support study set-up and delivery across the UK