Develop, Cost and Price a Proposal

All clinical research involving NHS sites, staff, patients or NHS data must be reviewed and assessed for costs by the relevant NHS Trust involved in the study. When preparing a clinical study please consider the following questions:

• Will any activities be taking place at NHS premises (e.g. outpatient clinics) and/or facilities (e.g. CRF) as part of the project?
• Will you be recruiting NHS patients as part of this project?
• Will you utilise NHS data or samples (either retrospective routinely collected data/samples, or prospectively collected data/samples) as part of your project?
• Will you utilise any NHS employed staff as part of your project?
• Will you identify your patients via the NHS?

If the answer to any of the above questions is Yes this requires an authorised costing from the NHS Trusts that you are working with.

Imperial College Healthcare NHS Trust (ICHT)

ICHT consists of the following hospitals: Charing Cross, Hammersmith, Queen Charlotte & Chelsea, St Mary’s and Western Eye Hospital.  Trust costs must be obtained from the ICH Trust Team using their Non-commercial costing tool for all applications. 

Please email imperial.admin_trustresearchcontracts@nhs.net to obtain this as early as possible in your application process. The title of your email should include Non-commercial costing request and the P-code of the proposal.

Once the non-commercial costing has been created by one of the ICH Trust Team, it will be approved by the relevant Divisional Research Manager (DRM) for each clinical division and returned to the requestor.

When is a SoECAT required?

All college-sponsored studies funded by a non-commercial organisation with NHS Trust costs will require a SoECAT (Schedule of Events Cost Attribution Template), if:

• The proposed study is intended for the NIHR CRN portfolio, the route through which support and Excess Treatment Costs are provided in England. This may include studies that will take place in a social care or public health setting.
• The research requires Health Research Authority (HRA) approval in England.
• The research will use NHS resources.

Some funders, namely research councils, require the completion of the SoECAT even if there are no NHS costs in the application.  

Authorisation is required from an AcoRD specialist in section 12 of the Study Information on page 1 of the SoECAT. The internal process for the SoECAT in the Faculty of Medicine can be found by clicking on the SoECAT Process Map.pdf (212KB). Please allow 20 days review time for approval and sign off by an AcoRD specialist.

SoECAT vs Costing Template

Please be aware that the SoECAT is not a costing tool and the relevant NHS costs still need to be obtained from any NHS trusts involved in the study.

ICHT

Costs to be included in the proposal must be taken from the ICHT non-commercial costing template. Where there is use of NHS resources, the applicant should complete as much of the "Study Information" on page 1 before seeking advice from the Trust team at imperial.admin_trustresearchcontracts@nhs.net

Royal Brompton & Harefield Trust

Internal Review SoECAT Process.  Before RBHT authorise SoECATs as single site and where ICL are Sponsor, RBHT require confirmation that the Sponsor has been involved in the completion process as per national guidance:

Funder Guidance on SoECATs

Funder guidance is available on completion of SoECATs on the NIHR SoECAT Guidance pages and on the IRAS guidance pages.

MRC and Wellcome Trust are the other main funders that require SoECATs for clinical research. However, the list of funders can be expanded to include any of the Association of Medical Research Charities (AMRC) members (such as Alzheimer's Research UK, Alzheimer's Society and British Heart Foundation, Cancer Research UK). To check if the medical charity you are applying to is a member please check the AMRC funder directory.

Worktribe

The Worktribe costing created by the PI/Dept must show each of the NHS Trust costs. In most cases NHS costs are categorised under Professional Fees and subsequently set up under 162132 or 162137 on ICIS dependent on whether VAT should be included in their costs. For further information please refer to the Research Office guidance on Research Partners vs Professional Fees. A detailed breakdown of Trust costs must be attached to Worktribe for record, along with a completed SoECAT.

Further guidance and Training for SoECATs can be found on the JRO webpage

Central Biomedical Services (CBS) provides and operates animal research facilities for the biomedical research community working to 'leading practice' guidelines, recognising that good laboratory animal welfare is an essential component of good laboratory animal technology and science. The multi-campus CBS facilities can accommodate a variety of species at various levels of discipline, including a full barrier unit, containment level 3 suites and quarantine facilities. Skilled and dedicated members of staff are able to provide professional help and advice.

Before commencing work within a CBS facility you must discuss your requirements with the Site Manager at the appropriate campus and be fully conversant with local rules and regulations.

Please click on the Central Biomedical Services (CBS) link to access the CBS Costing Tool and CBS Notification Form.

The Clinical Data Systems team aims to provide Investigators and Clinical Trial Teams across Imperial College with a comprehensive service to support the collection, management and analysis of data from clinical trials.  Please click on the Clinical Data Systems link to go directly to their website.

Please follow the ‌Clinical Data Systems - PDF (140k) guidance, as this applies to the Departments and JRO to ensure the costs are correctly added to InfoEd at the pre-award stage and the Clinical Data Systems costs are correctly transferred at post award stage. 

N.B. There is an exception for H2020 projects, and any other funders who also want to see an auditable trail of costs incurred.  This is because not all costs under H2020 can be recovered and therefore there needs to be a clear auditable trail of itemised Clinical Data Systems purchases on the subprojects set up.

Research England provides government funding known as “Quality-Related” (QR) funding which depends on factors such as quality of research and volume of research income. Additional support is also provided via the “Charity Support Fund” for eligible charitable income (referred to as C-stream) and the “Business Support Element” for industry collaborations.

Funder Group Guidance and C-Stream eligibility can be found in the Application Process on the Research Office webpage.
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Each Research Council provides an Industrial CASE studentship and more information about these applications can be found on the relevant research council website from the link provided. The process for CASE awards in the Faculty of Medicine is as follows:

Proposals should be submitted via the Joint electronic Submission (Je-S) system; however, these DO NOT need to be supported by a Worktribe proposal because CASE studentships DO NOT go through the Joint Research Office (JRO) under the P-code research ledger. 

Instead, notification should be sent by email to the department’s relevant finance manager, cc’d to faculty finance (Simon Passey), at least 5 working days prior to the submission deadline.

Proposals will appear in the JeS submitter pool along with ALL other research proposals administered by the JRO, so it is imperative the department finance manager and faculty finance (Simon Passey) are notified of this submission.

Once awarded, the department administration will need to request two new GL codes - a G code for the RCUK funding and an N code for the Industrial top-up.

The CASE agreement is negotiated and signed off by the JRO Contracts team (Agreements managed by JRO).