Pilot of the Activity Capture and Attribution Template (ACAT) and ACAT Review service for clinical research grants.

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1 Cancer Research UK Angel Building 407 St John Street London EC1V 4AD United Kingdom 06 February 2014 T Pilot of the Activity Capture and Attribution Template (ACAT) and ACAT Review service for clinical research grants. The National Institute for Health Research (NIHR) Clinical Research Network (CRN) in partnership with the Association of Medical Research Charities (AMRC) and selected NIHR programmes is piloting a new tool and service designed to help researchers and funders identify and attribute the activities in research studies. The Clinical Trials Awards and Advisory Committee (CTAAC), the New Agents Committee (NAC) and the Population Research Committee (PRC) at Cancer Research UK are one of a number of programmes that funders have agreed will participate in the pilot. Therefore, as you plan to apply to these research programmes for funding, you will also need to participate. Information about the pilot and your role in it as an applicant is provided below. Background: why we need the pilot In May 2012 DH published new guidance, Attributing the costs of health and social care Research & Development (AcoRD), to provide a framework to identify, attribute and recover the costs associated with research in the NHS in a transparent, robust and consistent manner. AcoRD also identified some research costs ( Annex A Part B ) that would be funded by DH either via CRN or through Research Capability Funding for AMRC funded studies. As part of the implementation of AcoRD, DH in partnership with the AMRC, NIHR CRN, and the Devolved Administrations, has developed a tool (Activity Capture and Attribution Template the ACAT) to help researchers capture and attribute correctly the costs of activities that are integral to a research project. The ACAT captures the tasks and activities that fall within the Annex A Part B Research Costs and NHS Support Costs categories, and gives a fuller picture of the activities of a research study. It is designed to be an addendum to existing research funding application forms and is intended to complement or replace work that researchers already need to complete to make an application for funding for research. We wish to pilot the ACAT to ensure it is fit for purpose before putting the template into use fully. Benefits of the ACAT and new advice and review process We hope that the completion of the ACAT, alongside the introduction of a new advice and review process for AMRC funded studies, will: Help researchers ensure that they have captured and attributed correctly all the activities required to undertake their research study; Help funders to identify and address any issues regarding attribution and funding at an earlier stage in the funding process thereby reducing delays to study commencement and limiting the need for funders to make additional resources available part way through a study; Help ensure that NIHR CRN is in a position to deliver the support required by a study when it starts by engaging and supporting researchers at an earlier stage of their grant application;

2 Improve the consistency and accuracy of activity capture and cost attribution; Help funders review the value for money of the study as part of their normal application review arrangements by setting out the study s full resource requirements. The NIHR CRN has established a group of AcoRD Specialists who have been trained specifically to: Assist researchers to use and independently complete the ACAT; Provide specialist advice to researchers on the CRN related AcoRD implementation processes, i.e. preapplication support service, completion of the ACAT and the ACAT Review; Carry out the ACAT Review for applications to AMRC members; Resolve any queries as a result of the ACAT Review working closely with the Funders and researchers. We hope that having trained AcoRD specialists across the NIHR CRN who will provide pre-application support and review the ACAT for researchers at the outset of them planning their studies will help to streamline study set up and delivery once a grant has been awarded. Purpose of the Pilot The ACAT and review process have already been subject to an initial testing phase and we are now ready to embark on a larger scale pilot involving a small number of AMRC funders and NIHR programmes. Full details of the ACAT tool, the pre-application support service and the ACAT Review process that will be included in the pilot are provided in Annex A to this letter. 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 ACAT has improved the consistency and accuracy of activity capture and attribution; Assess whether the review process is likely to deliver the anticipated reduction in delays to study commencement. The pilot will be evaluated by the AcoRD Implementation Working Group (with representatives from DH, NIHR, AMRC, MRC, the Devolved Nations and a number of charities), before making recommendations to DH on the way forward. In considering whether or not to roll out the ACAT and the advice and review processes, DH will want assurance that: the ACAT does not add unnecessarily to the burden of researchers completing application forms; there is no increase in overall bureaucracy; the benefits derived will outweigh any costs; and the ACAT and review are supported by the research community.

3 Role of the researcher in the pilot All researchers applying to the Clinical Trials Awards and Advisory Committee (CTAAC), the New Agents Committee (NAC) and the Population Research Committee (PRC) at Cancer Research UK are expected to complete the ACAT template and provide feedback on their experience of using the ACAT pre-application support and on the ACAT Review performed by NIHR CRN using the electronic on-line survey accessible from the NIHR CRN website The ACAT is available for download from the NIHR CRN website (see below), but an electronic copy of the ACAT has been attached to this letter for information. A help section is available within the ACAT which is designed to support its completion. We have made the following information available for download from the NIHR CRN website: a) Activity Capture and Attribution Template (ACAT) a help section is available within this template which is designed to support the completion of this b) Pre-application Support Service Information Pack c) The list of AcoRD Specialist contact details to help researchers through the process Please contact an AcoRD Specialist about any queries regarding the completion of the ACAT. Pilot timescale We hope to complete the pilot by early autumn 2014 subject to the funding panel dates of award schemes participating in the pilot, and to submit the pilot evaluation and review report with recommendations on the way forward to DH by 31 December NIHR CRN is leading on this pilot. If you would have any further questions, please contact the NIHR CRN via the central AcoRD CRNCC.Acord@nihr.ac.uk.

4 The ACAT, pre application support and the review processes Annex A 1. Activity Capture and Attribution Template (ACAT) 1.1. The Activity Capture and Attribution Template (ACAT) has been developed to: Support researchers to apply the AcoRD guidance published by Department of Health (DH) to identify fully 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. This enables the research funder(s) and the National Institute of Health Research (NIHR) Clinical Research Network (CRN) to gauge whether the study is appropriately resourced, and will offer value to the NHS. The ACAT is not a comprehensive costing template, and will not dictate the amount of funding paid by the grant funder(s), or the amount of support provided by the NIHR CRN. It will not be used as a pass-through model. Design and Structure The format of the ACAT is based on the CRN Industry Costing Template, as this has been successfully embedded in the research community for a number of years. It produces estimated costs of a study, attributed into the following categories as defined in DH AcoRD guidance: Research Costs (Part A). Currently only site-specific Research Costs are captured. Part A costs will not be visible to the researcher during the pilot. Future visibility will depend on feedback received during the pilot. Research Costs (Part B) NHS Support Costs NHS Treatment Costs It has been designed to promote consistent application of AcoRD principles by automating the attribution process, and eliminating much of the need for subjective decision-making Costs underpinning the ACAT 1.2. Many of the activities in the ACAT are also included in the CRN Industry Costing Template to ensure consistency and familiarity for the researcher. In these cases, the costs from the CRN Industry Costing Template (excluding overheads and capacity building element) have been used. Use of the ACAT 1.3. The aim is that, ultimately, researchers submitting a funding application to NIHR, MRC and any member of the Association of Medical Research Charities (AMRC) that is also an NIHR non-

5 commercial Partner will complete an ACAT in conjunction with their completed application form. Initially, NIHR CRN support services and the ACAT Review will be available to AMRC members and their applicants, with the support services and ACAT review eventually becoming available to all NIHR applicants Ultimately, researchers may choose to use this template to support the costing of their study, regardless of funder, as the tool will support attribution activities for any health research study. UK wide implementation 1.5. The ACAT asks researchers to estimate separately the number of sites that will be recruiting to the study in England, Scotland, Wales and Northern Ireland. Systems have been set up to allow smooth transfer of information for cross-border studies Researchers based in Wales are participating in the pilot. However, those 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. ACAT testing and consultation 1.7. The ACAT has been developed through consultation with a wide number of stakeholders, including researchers, funders, Department of Health, Clinical Trials Units, Devolved Nations and NIHR CRN staff. A test exercise was undertaken in June / July 2013, in which 12 researchers were given the opportunity to complete the ACAT, using pre-existing sets of documentation that would typically be available at the time of grant submission. Eight researchers took part, and 35 NIHR CRN staff carried out the ACAT Reviews with some ACATs being reviewed by more than one reviewer as part of the testing process. The feedback from those involved was then used to further refine the ACAT for use in this pilot. 2. Pre-application Support Service 2.1. It is recognised that researchers will require support to complete the ACAT. As well as other agencies supporting the research community (e.g. CTUs, RDSs, NHS R&D offices) the NIHR CRN will provide a pre-application support service The NIHR CRN has developed a number of resources and learning tools to support its own staff and colleagues in other agencies e.g. an attribution e-learning tool, an ACAT tutorial, a standard DH/CRN slideset and guidance documents. These tools are available via the NIHR CRN website. Webinars are also being planned from January 2014 to support learning. 3. Funders value for money review and ACAT Review 3.1. Funders will assess the grant application and as part of this activity, will determine whether the research represents good value for money.

6 3.2. In conjunction with the value for money review undertaken by the funders the NIHR CRN will complete an ACAT Review to ensure: The accuracy of the attribution of activities outlined in the ACAT and that they follow the principles of the AcoRD guidance That the suggested resource allocation within the ACAT is appropriate This will occur once the funder has confirmed they wish to award funding. The funder will be required to send the grant application form, completed ACAT, award in principle letter (where available) and any documents relating to any queries as a minimum document set, to the NIHR CRN to allow an ACAT Review to take place During the ACAT Review the NIHR CRN will review the following: All activities that should be listed in the ACAT have been included (regardless of attribution). Research (Part B) and NHS Support activities have been attributed correctly (i.e. nothing there that should not be, and nothing missing). While checking the above, if it is noticed that there is an error in the attribution of any Research (Part A) activities or NHS Treatment activities, the AcoRD Specialist will flag these to the funder. However, it is the responsibility of the funder to ensure that research costs have been attributed correctly Once the ACAT Review has been completed the NIHR CRN and Funder will work together to resolve any issues to ensure that the study is fully costed, activities are attributed correctly and that the suggested resources are appropriate for successful study delivery. Both parties may also need to liaise with the researcher, as required The NIHR CRN Coordinating Centre will oversee and coordinate the ACAT tool.