SoECATs in Grant Applications
Key Points to Note:
- The SoECAT is not a costing tool for us to calculate NHS costs.
- It is the responsibility of the PI to ensure that the SoECAT is completed.
- The SoECAT is an NHS document, for the NHS to complete, or for us to complete in partnership with the NHS. We have no expert knowledge on how to complete these in house, however the Yorkshire & Humber CRN can offer advice on this through their early contact and engagement service.
- The SoECAT (completed by/with the NHS) is then approved (by email) by the local Sponsor signatory. If this is the University of Sheffield, first point of contact for this being the Department Health and Social Care Research Governance Contact.
- The NIHR Y&H CRN then checks and approves the SoECAT before it can be uploaded with the grant application ahead of the funder deadline.
|What is a SoECAT?||
A Schedule of Events Cost Attribution Template (SoECAT) is a tool for the NHS to understand the type of NHS activities you plan to undertake within your research project and calculate the average per patient excess treatment cost. This ensures appropriate funding (separate to the research costs in the research grant) flows back to the NHS for the full costs of your project.
This tool and process applies to all types of NHS involvement, not just interventional/investigational studies but also to projects collecting/using patient samples or data or questionnaires. A SoECAT needs to be completed and approved before the submission of a grant application to make sure that key NHS approvals and checks that you will need once the grant is awarded can be given (i.e. Health Research Authority, NIHR portfolio status).
A SoECAT is NOT a tool for universities to calculate NHS costs. The guidance is very clear that a SoECAT’s purpose is not for calculating the costs of a research study and it would be unusual for the summary figures generated in the SoECAT to closely reflect the research costs in the grant application.
Download the SoECAT here.
|When is a SoECAT needed?||
SoEAT is needed for all clinical and health research applications that will be undertaken in England. This tool and process applies to all types of NHS involvement, not just interventional/investigational studies but also to projects collecting/using patient samples or data or questionnaires.
If in any doubt about whether a SoECAT is needed for a grant application please consult the guidance provided by the research funder or contact the funder to discuss. In many cases the guidance for the application will be explicit, e.g. for the NIHR, MRC and other large health research funders. NB: the NIHR requires the inclusion of a SoECAT for most, if not all, grant applications even when the NHS is not directly involved in the project.
To navigate the process, you will need to know which organisations are acting in the following roles for the project(s) described in your grant application.
NB: Sometimes the University of Sheffield, or other organisation, will take on more than one of these roles for your project.
NB: In very rare occasions they will not be a pre-identified Lead NHS site for a research project. Site identification will happen as part of the study methodology. In this case the CRN will support the completion of the SoECAT.
NB: Where a SoECAT is being requested by the funder, but there is no NHS involvement in the project, a SoECAT that is blank beyond the first page must still be validated by the CRN before submission.
|STEP 1: Who completes a SoECAT?||
The lead NHS organisation involved. If your project involves the NHS, you will need to approach the lead NHS organisation in your project for help to complete the SoECAT form, based on the project plan and timetable you have developed together for any activities that involve the NHS. You can do this via your NHS co-investigator, or direct with the Research Office for the NHS organisation. The SoECAT should be completed by that organisation, based on the information you give them about your study, and their knowledge of how the study will fit into the specific clinical setting.
If there is no NHS organisation involved, the PI must complete the front page details of the SoECAT.
|STEP 2: Who approves the SoECAT?||
The SoECAT will need to have the approval of the study Sponsor. Where an NHS organisation or commercial company is to the be Research Governance Sponsor they will provide this approval.
Where the University of Sheffield is to be the Research Governance Sponsor, first check that the type of study you are planning is in line with the University's research governance policies. The University will not sponsor clinical trials of investigational medicinal products (IMP-trials) or clinical investigations of devices which fall under the UK Medical Devices Regulations. Other types of human-interventional study presenting significant risks may require specific approval before the University will agree to act as sponsor.
To obtain approval the lead researcher will need to confirm that the:
i) proposed project is a type of study that the University of Sheffield can sponsor
|STEP 3: Who validates the SoECAT?||
The local NIHR Clinical Research Network (CRN) will need to review and validate your SoECAT before it can be submitted to the funder.
Send the following information to the local CRN to request validation:
The CRN will need a minimum of 10 working days to review and validate the SoECAT.
The SoECAT can now be submitted to the funder as part of your grant application.