Delivering clinical research to make patients, and the NHS, better

ACAT Pilot Amber O’Malley, CRN Funding and Contracts Manager CRN AcoRD Business Lead

Session overview

• Overview of ACAT Pilot Project – Amber O’Malley• Activity Capture and Attribution Template (ACAT) – Baljit

Galsinh• Walkthrough of the ACAT – Karen Hampshire• Q&A

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AcoRD Implementation

AcoRD guidance • Published May 2012• Applies to new grant applications submitted after 1 October 2012

Primary reasons for change:• Improving the consistency of cost attribution; and• Encouraging more consistent funding of the costs of research

https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research

ACAT Pilot• NIHR Clinical Research Network (CRN) is leading a pilot to support

implementation of AcoRD guidance working in partnership with DH, NIHR, AMRC and range of charities

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Tools and services to be piloted

New tool and services designed to help researchers and funders identify and attribute the activities appropriately in research studies in line with AcoRD guidance

Activity Capture and Attribution Template (ACAT) • Designed to support researchers to apply the AcoRD guidance to identify and

attribute correctly the activities being undertaken as part of a research study• Produce estimated costs of study activities, to give an indication of the resources

required to deliver the study.

Pre application support service• AcoRD Specialists / NIHR provide support on attribution and independent

completion of ACAT• List of AcoRD Specialists available on NIHR CRN website• Other organisations e.g. CTUs, RDSs also provide range of support services

ACAT Review service• NIHR CRN / CCF / NETS CC check attribution and resource

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Aims of the Pilot

The purpose of the pilot is to:

• Obtain feedback on the usability of the ACAT• Identify any types of research study where the ACAT is

inappropriate• Assess the level of training and support that researchers and

funders will need to use the ACAT• Assess whether the NIHR CRN AcoRD specialist role meets the

needs of researchers• Assess the resource implications for NIHR CRN of rolling out the

ACAT and the advice and review process for DH, funders, NIHR CRNs and researchers

• Assess whether the review process is likely to deliver the anticipated reduction in delays to study commencement

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ACAT Pilot Project

• Pilot exercise started in December 2013 and due to conclude in the autumn of 2014

• Range of funders participating from AMRC charities and NIHR programmes – Cancer Research UK– Arthritis Research UK– Prostate Cancer UK– Diabetes UK– NIHR

• Evaluation exercise commenced and recommendations to DH late 2014

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UK Wide Working

Studies led in Wales

• Welsh researchers are included in the ACAT pilot and required to use the ACAT as part of their applications submitted to participating funders

• Pre application support and the formal review process for Welsh led studies will be undertaken centrally by the NISCHR AHSC Contract and Costing Service

Studies led in Scotland

• Researchers based in Scotland are exempt from the ACAT pilot

• NHS Research Scotland is developing its own costing system which will provide similar information to the ACAT

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Feedback and Evaluation

• All funders, researchers and AcoRD Specialists participating in the pilot will be asked to provide feedback on their experience of using the associated CRN processes i.e. the ACAT, pre application support and the ACAT Review.

• Various mechanisms in place to support evaluation approach

• May not be directly involved in the pilot but can also feedback your comments via CRN AcoRD email

CRNCC.Acord@nihr.ac.uk

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Benefits of the ACAT, pre application support service and ACAT Review

Completion of the ACAT, the introduction of a new advice and review process will:

• Help funders to identify and address any issues regarding attribution and funding at an earlier stage in the funding process

• reduce delays to study commencement and • limit the need for funders to make additional resources

available part way through a study• Improve the consistency of cost attribution• Support early engagement between researchers and NIHR CRN

• enables NIHR CRN to plan resources to support effective delivery

• Help funders review value for money of the study by setting out the study’s full resource requirements

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Learning Resources

All learning resources are accessible via the NIHR CRN website:• E-learning attribution tool• DH slide set• CRN slide set• ACAT Briefing sessions • ACAT tutorial (~45 minutes): video format

• Visit: http://www.crn.nihr.ac.uk/can-help/funders-academics/support-for-non-commercial-studies/acord/

• Contact crncc.acord@nihr.ac.uk for queries

Delivering clinical research to make patients, and the NHS, better

ACAT Baljit Galsinh CRN Management Accountant

The Brief

• Create a tool that supports the consistent application of AcoRD principles, and estimates the costs of the study

• Use Industry Costing Template as a starting point

Purpose of the ACAT

• To support researchers to apply the AcoRD guidance and correctly attribute the activities being undertaken as part of a research study

• To produce estimated costs of these activities, to give an indication of the resources required to deliver the study

Purpose of the ACAT

• The ACAT is primarily a cost attribution tool

• The ACAT is not a comprehensive costing template, and therefore will not dictate the amount of funding paid by the grant funder(s), or the value of support provided by the NIHR Clinical Research Network

• Funding applications should still be costed using existing local costing tools

• ACAT costings based on activities, not individuals

Scope of the ACAT

• Research Costs (Part A & B)

• NHS Support Costs – but not central management and sponsorship costs

• NHS Treatment Costs (the ACAT does not calculate excess treatment costs – these must be calculated separately and entered directly)

Source of costs in the ACAT

• Costs (and time estimates) from CRN industry costing template (excluding overheads and capacity building element)

• The costs within the ACAT are being continually reviewed, in 2014 the investigational costs will be reviewed.

• Research (Part A) costs hidden to avoid impression that ACAT dictates funding amount

ACAT development

• Designed to be as automated as possible

• Involved experts from across the NHS

• Not expected to capture 100% of studies (may have to use template creatively)

• Appropriate balance must be struck between complexity and accessibility

Delivering clinical research to make patients, and the NHS, better

ACAT PilotActivity Capture and Attribution Template (ACAT) Pre-Application Support and Advice Karen Hampshire, Lead RM&G Manager (AcoRD Specialist)CRN: West Midlands

02/07/2014

What is the ACAT for Investigators?

1. A tool that supports the consistent application of AcoRD principles and estimates the costs of the study

What’s the purpose of the AcoRD

Specialists?

1. To support investigators to apply the AcoRD guidance and correctly attribute the activities being undertaken as part of a research study for AMRC funder (not NIHR funding streams)

2. To produce estimated costs of these activities, to give an indication of the resources required to deliver the study at SITE level.

What needs to be remembered?

1. ACAT costings based on activities (the primary purpose of the activity), not individuals

Reality

1. Don’t assume there is a general understanding of the AcoRD Guidance– understanding the difference between attributions– understanding of Research Part A & Part B costs

2. Received requests for support for NIHR funding streams as well AMRC– Locally we support all funding streams if possible

3. Requested investigators to give us 2 weeks notice before funding submission– Calls for support come late (30mins before the deadline)

4. Contacted mainly by a mixture of CTU’s, Project managers within R&D Departments– No direct contact from CI’s yet

5. Key Questions:– ‘What is an ACAT form?’– ‘Do I need to complete one of these?’– ‘Why do I need to complete one of these?’

Assumptions

1. Sent out communications to our local research community - for many it was the first time they have heard about ACAT and even AcoRD! 1. ACAT Pilot on the NIHR CRN website2. AcoRD Guidance of DH website

2. The ACAT should have been completed by the investigator so should be intuitive1. This is not always the case as it would have been the first time they

would have seen this form2. Put off by the size of the form which they would have need to complete

over and above the funding application

Questions from Investigators

1. Can you do my study costings please?1. Unfortunately not. These need to be done in association with your

R&D Departments and Finance Departments. Pre-Application support would not have access to this type of information. Their remit is to support the completion of the template, help identify all the activities and assist in attributing correctly

2. What is the difference between ‘Per Participant costs’ and ‘Study Costs’1. ‘Per participants costs’ are study activities which are clearly linked

to participants (Questionnaires, investigations, medical history informed consent etc.)

2. ‘Study Costs’ are activities which are generally not linked to participants and occur less frequently during the study

Questions from Investigators

• The finance calculations in the ACAT are different. Why?– The cost of the activities are taken from the Industry costing

template with overheads, capacity building element and MFF stripped out. The costs are national averages and not local costs

• Does the completion of the ACAT Template have an effect on my application?– No. This is a pilot and is being run in parallel with the application

process. The application process will review the finance information given as part of the application form

Requests for Pre Application Support

1. Should be requested as early as possible1. Already have some deferred RfPB Sept closing

dates2. Request can come from anywhere3. Think about completing a ‘Schedule of Events’4. Initially email or telephone but should arrange for a face

to face meeting with your AcoRD Specialist

My experience of Pre Application Support with a research team1. Initial discussions take 20-30 min to understand the patient

pathway for the study2. Pre Application Support review of the ACAT takes around 60-90

mins depending on the complexity of the study or how well the protocol has been developed.

3. Individual 1:1 support via emails and telephone 10-30 min each after initial meeting.

4. Help is out there! 1. If we are not sure then the AcoRD Specialist have recourse to

contact other AcoRD experts.

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AcoRD Specialists (Central) Karen HampshireKirsty Hunter 

ACATs supported 

2 x CTAAC 5 x RfPB 1 x CRUK 1 x Care home study (trial only)9

ACATs submitted 

2 x CTAAC 2 x RfPB1 x CRUK5

ACATs deferred 

3 x RfPB

Number of training sessions 

6

Number trained 

71

Organisations trained Network staff, RDS, CTUs, R&D Departments, Universities  

ACAT information dissemination at events 

BBC CLRN Showcase Event, 17.03.14UHBNHSFT Research Showcase Event, 20.05.14Communication Updates – ‘Fridays Email’ 

What have we done?

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Advice 1. Use the pre-application support service!!

2. Contact an AcoRD Specialist before you have looked at the ACAT if you are new to it

3. Use the ‘HELP’ tab and Guidance section in the ACAT for more detail on attribution

4. Highlight/ list all activities from the grant application

5. Use the automated section as much as possible

6. Use the drop down menus to easily identify all the relevant activities

7. Don’t spend too much time searching for an activity

8. Be aware of potential quirks in the tool (pilot)

9. Don’t be conscious of keeping costs down!

10. Record your feedback to inform the pilot ~ the quirks

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Benefits 1. Excellent tool for addressing any confusion over

attribution2. Supports the AcoRD guidance and may be used to

answer questions not addressed in the AcoRD FAQs

3. Investigators are able to identify potential costs earlier

4. Better understanding of cost attribution all round 5. More confidence in panel members funding study6. Open and transparent

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AcoRD Specialist for CRN: West Midlands Central TeamKirsty Hunter Karen Hampshire • Telephone: 0121 627 2843• Email: cspbbcclrn@uhb.nhs.uk

North TeamMary Anne DarbyPam Devall• Telephone: 0845 602 6772 • Email: sch-tr.wmnclrn@nhs.net

South TeamKatie WilliamsRachel Davis• Telephone: 01564 711 711 • Email: uhc-tr.wmsclrn@nhs.net