Centres of Excellence for Regulatory Science and Innovation

What the assessor looks for

• is of excellent quality and importance within or beyond the field(s) or area(s)
• has the potential to advance current understanding, or generate new knowledge, thinking or discovery within or beyond the field or area
• is timely given current trends, context, and needs
• advance current understanding, or generate new knowledge, methods, tools, standards, approaches or thinking, within a chosen field or area of regulatory science
• articulate the regulatory science challenge(s) the proposed CERSI will address and explain their significance
• explain how the proposed CERSI aligns with one of the strategic themes set out in this funding opportunity
• explain the potential for the work to inform regulatory policy, practice, guidance, methodologies or decision-making
• bring together the critical mass of expertise needed to address the identified regulatory science challenge(s)
• build effective partnerships with industry and other relevant stakeholders
• standards or approaches
• potential benefits to patients and the public
• the health system

A filled dot only means your answer mentions that ground. It is not a judgement of how well.

What the assessor looks for

• is effective and appropriate to achieve your objectives
• uses a clearly written and transparent methodology (if applicable)
• summarises the previous work and describes how this will be built upon and progressed (if applicable)
• will maximise translation of outputs into outcomes and impacts
• describes how your, and if applicable your team’s, research environment (in terms of the place and relevance to the project) will contribute to the success of the work
• describe your approach to the proposed programme of research. You should describe how its component work packages or activities form a coherent programme, addresses the CERSI’s overall vision, aim and objectives
• provide your CERSI programme plan including key milestones, dependencies and timelines, in the form of an embedded Gantt chart or similar
• demonstrate access to the appropriate services, facilities, infrastructure, or equipment to deliver the CERSI programme
• where relevant, explain how cross-cutting regulatory science considerations identified in the funding opportunity inform the proposed programme of work
• if applicable, explain and justify how you will approach diversity and inclusion in the study population and follow the MRC embedding diversity in research design policy
• demonstrate that the proposed CERSI programme of work is appropriately focused and achievable within the timeframe, scope and resources of the award
• show how you will use male and female animals or tissues and cells from female and male donors, if applicable, in your research. If you are not proposing to do this justify why, if applicable

A filled dot only means your answer mentions that ground. It is not a judgement of how well.

What the assessor looks for

• be effectively and inclusively led and managed, with clear systems, structures, roles, responsibilities, oversight and accountability for programme delivery
• establish and implement effective governance and decision-making arrangements across collaborating disciplines and organisations
• work collaboratively with MHRA and the CERSI programme’s oversight structure to maintain alignment with current regulatory science needs
• maintain awareness of emerging scientific and technological developments relevant to the CERSI and identify their implications for regulatory science
• identify and prioritise activities, including the processes and criteria for initiating, adapting or discontinuing work where appropriate
• monitor progress against agreed milestones, deliverables and intended outcomes, and manage risks or underperformance
• maintain sufficient flexibility in programme management and decision-making arrangements to respond to new priorities while retaining coherence with the overall CERSI vision, aims and objectives

A filled dot only means your answer mentions that ground. It is not a judgement of how well.

What the assessor looks for

• population cohorts, longitudinal studies, genetic, omics and imaging data, biobanks, and other collections that are potentially a rich resource for the wider research community: maximum of 1,500 words
• all other research, less complex, the plan may be as short as 500 words

A filled dot only means your answer mentions that ground. It is not a judgement of how well.

What the assessor looks for

• the relevant experience ( appropriate to career stage ) to deliver the proposed work
• the right balance of skills and expertise to cover the proposed work
• the appropriate leadership and management skills to deliver the CERSI programme and your approach to develop others
• contributed to developing a positive research environment and wider research and regulatory science community
• contributions to the generation of new ideas, tools, methodologies, or knowledge, this may include your previous funding and key outputs such as publications
• the development of others and maintenance of effective working relationships
• contributions to the wider research and innovation community
• contributions to broader research or innovation users and audiences and towards wider societal benefit, including public partnerships
• the appropriate breadth and balance of multidisciplinary expertise across regulatory science and the scientific, methodological and translational disciplines relevant to the proposed CERSI
• experience of working collaboratively across relevant sectors and disciplines, including with regulators and other research users, as appropriate

A filled dot only means your answer mentions that ground. It is not a judgement of how well.

What the assessor looks for

• collaboration agreements
• definitions of basic or applied research
• internationally based companies
• subsidy control
• intellectual property (IP) arrangements
• fully flexible and gated contributions
• the ICF assessment criteria
• Name the industry or company project partner considered under ICF.
• Indicate whether your application is basic research or applied research.
• Explain why, in the absence of the requested UKRI funding, the collaboration and the planned research could not be undertaken.
• State whether your application is under the category of fully flexible contribution or gated contribution (based on the IP sharing arrangements with the industry or company partner).
• Outline the pre-existing IP (‘background IP’) that each partner, including the academic partner, will bring to the collaborative research project and the terms under which partners may access these assets.

A filled dot only means your answer mentions that ground. It is not a judgement of how well.

What the assessor looks for

• name of facility, copied and pasted from the facility information list (DOCX, 43KB)
• proposed usage or costs, or costs per unit where indicated on the facility information list
• confirmation you have their agreement where required

A filled dot only means your answer mentions that ground. It is not a judgement of how well.

What the assessor looks for

• the relevant ethical and RRI considerations, including both the research or topic area itself and the design and delivery of the project
• the wider implications of the proposed work, and how you will maximise the positive societal, environmental, and economic benefits arising from the project, while minimising unintended negative impacts, such as research misuse or accidental harm
• how you will manage these considerations throughout the lifecycle of the project

A filled dot only means your answer mentions that ground. It is not a judgement of how well.

What the assessor looks for

• project staff
• significant travel for field work or collaboration (but not regular travel between collaborating organisations or to conferences)
• any equipment that will cost more than £25,000
• any consumables beyond typical requirements, or that are required in exceptional quantities
• all facilities and infrastructure costs
• all resources that have been costed as ‘Exceptions’
• support for public and patient involvement and engagement. See Payments to public partners
• support for preserving, long-term storage, or sharing of data
• support for international co-leads, demonstrating this is within the 30% costs cap for co-leads from high-income countries, India and China. There is no cap on costs requested for international applicants from DAC list countries
• NHS research costs, when they are associated with NHS studies
• animal costs, such as numbers that need to be bred or maintained and to maintain high welfare standards
• are comprehensive, appropriate, and justified

A filled dot only means your answer mentions that ground. It is not a judgement of how well.

What the assessor looks for

• how public partners have contributed to or co-designed the application
• how public partners will be involved in conducting or supporting the CERSI programme
• how public partners will be selected
• provide the names of applicants who are public partners and their ‘Role type’, where applicable

A filled dot only means your answer mentions that ground. It is not a judgement of how well.