Where is your study in the process?

To determine where the study is at in the process, and what the next steps are, please use the flow chart for guidance or the accessible flowchart

The following guidance can also be used to help aid understanding of the flow chart

Funding application is submitted and validated

The researcher must prepare and submit their funding application to the Funder.  Researchers are usually required to complete the Schedule of Events Cost Attribution Template (SoECAT) as part of research funding applications for non-commercial studies.  The SoECAT is an application whose purpose is to capture the different activities associated with clinical research and attribute them accordingly as ‘research activities’, ‘support activities’, or ‘treatment activities’ in line with the national guidance document “Attributing the costs of health and social care research and development” (AcoRD). Read the full SoECAT guidance for more information.

The researcher should send their completed SoECAT to their NIHR Local Clinical Research Network(LCRN) AcoRD Specialist to be authorised. Should researchers require support to complete the SoECAT, they should contact their LCRN Study Support Service as early as possible to request attribution support. 20 working days prior to the submission of a funding application the absolute minimum time required to ensure sign off by the submission date.   A maximum of 10 additional working days (prior to funding submission) from confirmation of AcoRD Specialist reviewer is suggested to provide leeway for any amendments or escalations to be resolved. The AcoRD Specialist in the Lead LCRN (meaning the LCRN that takes overall responsibility for the study within the NIHR CRN) must approve the final completed SoECAT prior to submission of the funding application for the application to be valid.

Funder makes a decision on funding application 

Once a SoECAT is validated by the AcoRD specialist the completed SoECAT and application form is submitted to the Research Funder. If the research funding application indicates that the study will exceed the high cost threshold, the research funder will notify NHS England’s High Cost Review team 

If the research funding application is successful and:

• the ETCs for the study exceed the high cost threshold, the Research Funder notifies the High Cost Review Team to commence a clinical alignment review 

• is not subject to any further amendments and the ETCs are less than the high cost threshold, the researcher, once they have been notified by the funder that their application for funding has been successful, will notify the AcoRD specialist for submission to triage 

• is awarded subject to changes, the researchers will revise and resubmit the application to the Research Funder. This may require the SoECAT to also be revised, revalidated by the AcoRD Specialist and resubmitted to the funder.

If the funding application is awarded subject to changes, the researcher must make those changes and resubmit along with a revised SoECAT as necessary.

The Funder will then review the revised funding application and decide whether to reject it or award it. 

If the Funder has decided to approve the funding application, they must notify the High Cost Team if the application is above the high cost threshold.

If a researcher receives confirmation that research funding is awarded, the research team must inform the Lead LCRN’s AcoRD Specialist for the study as denoted on the front of the agreed SoECAT form. If funding has been awarded dependant on changes to the study design, the team must inform the AcoRD Specialist so that any subsequent changes to the attribution of study activities are reflected, if appropriate, in an amended and re-validated SoECAT.

High cost review

At application stage and prior to a funding decision being made (final application stage for applications that have a two or more stage process), the research Funders notify the High Cost Team about any studies that may exceed the high cost threshold if funded. The High Cost Team provisionally decide on a commissioner and make preparations for a High Cost Review by identifying a suitable panel should the research application be successful.

Once the funder has made the decision to fund the research funding, the Research Funder notifies NHS England and DHSC about any studies with ETCs above the high cost threshold (i.e. where ETCs are higher than the thresholds). In addition, and in parallel, the AcoRD specialist will also identify any high cost studies thus ensuring that all studies requiring a review are identified as soon as possible.

Flowchart of the high cost ETC assessment process [PDF}. If you require an accessible version of this flow-chart, please email: england.highcostETC@NHS.net

The research funder indicates research funding approval. The High Cost Team will confirm the responsible commissioner for funding ETCs and begin the high cost review process.

For all studies with ETCs that exceed the High Cost Threshold an assessment of clinical alignment and therefore value to the NHS will be conducted prior to agreement to fund ETCs.

For High Cost studies where the ETCs are mainly related to specialised service directly commissioned by NHS England, NHS England will undertake a clinically led assurance process to ensure the study is of high value to patients and the NHS prior to agreeing ETC funding. This will run in parallel to the finance assurance process to agree ETCs. The assessment of clinical alignment will be undertaken on a case by cases basis by;

1. The relevant Regional Medical Director or nominated clinical expert and,

2. The Clinical Co-Chair of the relevant clinical or commissioning programme

For studies where the ETCs mainly relate to ICB commissioned services an assessment of clinical alignment will be undertaken on a case by case basis by:

1. The relevant NHS England National Clinical Director or nominated clinical expert,

2. The Innovation, Research and Life Sciences Director or Deputy Director for Research from NHS England and,

3. Relevant clinical expert designated by DHSC.

In both cases, the possible outcomes of the assessment are:

1. Clinical alignment agreed and therefore ETC funding is supported.

2. Clinical alignment is in question. There will be discussion and negotiation with the lead investigator/Sponsor and Funder to attempt to agree any changes to the protocol/methodology that will enable alignment to be agreed:

1. Agreement to changes to ensure clinical alignment and ETC funding is agreed.

2. Following discussion and negotiation agreement to amend the study to bring into clinical alignment is not possible. ETCs will not be funded.

Please contact england.highcostETC@NHS.net and highcostetcs@dhsc.gov.uk with further questions on your study.

The Accord Specialist must complete a SoECAT and submit to Triage for review

Where the study will incur ETCs, this contact will trigger the process followed by AcoRD Specialists to submit the study to the CRNCC triage team to determine:

a)    if the study is eligible for automatic ETC funding

b)    the responsible commissioner for ETCs

c)    whether the study is categorised as having “high cost” ETCs. If it is a high cost study, it will be sent to the high cost team

See the full SoECAT guidance for more information. The AcoRD Specialist will inform the research team of the outcome and next steps.

Triage will provide a commissioning decision

The Commissioning decision provided by the Triage team is issued to Study Representative and LCRN and the CPMS study record is updated. 

If the study is commissioned as ICB, a member of the ETC finance team will be notified of the ICB commission decision, as soon as the study has reached the status of “In Setup, approval received”. 

Once notified, a study review will be conducted and a payment model will be recommended and sent to the Chief Investigator and Sponsor of the study for approval or discussion. Once approved, payments will be made as per the timetable and payment principles subject to any provider threshold set by the NHS England.

If commissioned as Specialised Commissioning, please contact  england.speccommetcs@nhs.net who will be able to help you further

If commissioned as Public Health please contact  interventioncostenquiries@dhsc.gov.uk who will be able to help you further

If amendments are required, the Study representative must make their updates to the SoECAT and submit to triage