West of England Study Support Service frequently asked questions

General Questions

What can the Clinical Research Network (CRN) Study Support Service offer me?

We will start by opening a conversation with you about your study. We will ask about what stage it is at, the type of research and the specific needs you have.

We also have the following resources to support you:

A team who have a wealth of research experience and excellent local knowledge. We can discuss the best locations to recruit the right participants for your study in clinical & non-NHS settings.
Links with 14 other Local CRNs, across England, covering 30 clinical specialties.
Access to patients and the public (PPIE) who can give their opinion on your research.
Training opportunities for new and more experienced research staff.
We can support recruitment to your study - either through funding or support staff.
Access to our Research Delivery Managers (RDMs). They take responsibility for particular therapeutic areas. RDMs have experience of actually delivering research studies and may be able to assist with finding solutions to support the successful delivery of your study.

How do I know who my lead CRN is?

The Local CRNs are split into regions, your lead CRN will be the area where the Chief Investigator’s employing institution is. Check the Local Clinical Research Networks map if you are unsure. We are number seven, West of England.

Eligibility Questions

How do I know if I am eligible for support?

The CRN helps studies that are potentially eligible to be on the NIHR CRN Portfolio. Read more about the eligibility criteria.

If you are unsure if your study would be eligible or not then please email the Study Support Service team.

How do I get my study on the NIHR Portfolio?

When submitting your Integrated Research Application System (IRAS) application tick yes to filter question 5b. If you need directions to this please email the Study Support Service team.

In addition, if you are applying for approvals through the Health Research Authority’s combined review service then you must complete a CRN application form. There is a training video explaining the form and we are very happy to talk you through this if needed, please contact the Study Support Service team.

I am not recruiting NHS patients, can I still be on the NIHR Portfolio?

Yes we support non-NHS studies. If your health and social care research meets all the criteria then you will be eligible for support.

My study is already open, can I join the NIHR Portfolio now?

Yes, if you meet the eligibility criteria. Please email the Study Support Service team and we can discuss the options and send you the form you need to fill in. We will also need the following documents:

IRAS Form
Latest Protocol
Confirmation of funding
HRA approval (if applicable)

SoECAT and AcoRD Questions

What is AcoRD?

AcoRD stands for Attributing the costs of health and social care Research and Development.

It is a document from the Department of Health and Social Care which establishes who should pay for which activities in health and social care research. It splits the cost into three categories:

Research Costs are activities that take place to answer the research question and will end when the research does. These costs will come out of the awarded grant.
NHS Treatment Costs the care costs which would continue if this care was continually provided after the research ended and became standard of care.
NHS Support Costs the patient care costs that stop even if the care becomes the standard of care. This includes screening patients and obtaining informed consent.

What are Excess Treatment Costs (ETCs)?

ETCs are the additional costs, above standard of care, of treating a patient in a research project. In non-commercial research the NHS pays for the standard of care treatment for a patient. If, as part of a trial, a patient is being treated through research then there is a system for paying the NHS provider for any additional costs, through the CRN using the SoECAT as the tool to decide how much.

Some research interventions also create a cost saving to the NHS.

To pay the ETCs to the NHS providers there are a number of models. Which one your study uses is a choice for the Sponsor but we are happy to talk through the different options.

Any questions about ETCs, please email the Study Support Service team.

What is a SoECAT?

A SoECAT stands for Schedule of Event Cost Attribution Tool. It is a tool used to attribute the costs of non-commercial research correctly. To ensure research grants, the NHS and the NIHR are paying for their parts.

A SoECAT will work out if the cost of treating a patient in a research study would cost more or less than their standard care. If there is any cost difference (known as an ETC) then this is paid for in a specific way through the NIHR.

A SoECAT is used as a tool by sites when conducting Capacity and Capability (C&C) assessments in understanding what is involved in undertaking this research project. It forms part of the local information pack that is sent to each site.

Download the SoECAT template. (Template A & B are the same except for Template B you can have more than 5 arms to a study).

Do I need a SoECAT?

Only non-commercial studies might need a SoECAT.

If you are applying for research funding check with the funder if a validated SoECAT is necessary. All NIHR, second round, funding submissions and many charities now require a SoECAT with your funding application.

You will also need a SoECAT for your IRAS application if your study has one more than one site.

Can you help me fill in the SoECAT?

We don’t fill in theSoECAT for you but we can talk you through it and provide advice. please email the Study Support Service team.

We recommend talking to your local R&D Office and/or Finance teams who can assist you.

How do I get a validated SoECAT?

Send your draftSoECAT to the Study Support Service team and one of our AcoRD Specialists will be allocated to review your SoECAT. They will review it and get in touch with you with any queries, this may be over email or in a meeting. When all the queries are resolved we will validate the SoECAT and email it to you ready for you to attach to your funding or IRAS application.

My funding deadline is tomorrow and I haven’t completed a SoECAT yet, what shall I do?

We ask for a minimum of ten working days to review and validate a SoECAT and so unfortunately we wouldn’t be able to help you. If you can’t delay your submission then you will need to explain to the funder why no SoECAT was included, it may be that your application is not valid.

We recommend always reading the funding criteria well in advance.

However, no matter how late, please contact the Study Support Service team to see if we can help.

Can I use the same SoECAT for my funding and IRAS applications?

Yes you can, if nothing has changed in your study that affects the SoECAT.

However the SoECAT can be amended if the activities have changed between funding and IRAS applications. We will then validate the second one in the same way.

Does the study Sponsor need to see the SoECAT?

Yes, the study Sponsor must review and approve the SoECAT before it is sent to the CRN. We have close relationships with the local study Sponsors, we can link up and have joint meetings if this is useful.

I am adding some Patient Identification Centres (PIC) to my open study. Do they need a SoECAT?

Yes, if adding PICs for the first time. Each site type needs a different SoECAT. This will have to be submitted with your amendment to add the PICs and we will validate this SoECAT.

You use too many acronyms! Is there any help?

AcoRD: Attributing the costs of health and social care Research & Development

Annex A: Part of AcoRD: List of common research activities attributed to the Research Costs, NHS Treatment Costs and NHS Support Costs

CI: Chief Investigator

CPMS: Central Portfolio Management System (our database)

CWoW: Combined Ways of Working, also called the combined review service - the HRA’s new application system

EC&C: Early Contact and Engagement

ETC: Excess Treatment Costs (the difference between the Treatment Costs in a research study and the costs of the existing standard treatment)

HRA: Health Research Authority

NIHR: National Institute for Health Research

LCRN: Local Clinical Research Network

PIC: Patient Identification Centre

SoC: Standard of Care

SoECAT: Schedule of Events Cost Attribution Template. Download the latest SoECAT templates and guidance. (Template A has 5 arms, template B has 15 arms.)

SSS: CRN Study Support Service

Support costs: Additional patient care costs paid by NIHR for supporting research

Research costs: Costs of the research

RDM: Research Delivery Manager (part of the CRN team)

Treatment costs: The cost of treating a patient

WE CRN: West of England Clinical Research Network

WE CRN AcoRD: Specialists WE CRN Staff trained to provide the SoECAT Validation service in the region