A1.3 Chief executive/Board engagement to support research activity. Is unaware of the need and benefits of executive/Board engagement in research. Understands the need and benefits of chief executive/Board level engagement in research but is not part of their role. Understands and is proactive in promoting/seeking chief executive/Board engagement to support research in the organisation. Leads on the organisation’s R&D Operational Capability Statement (OCS) for Board consideration and sign off and publication. Understands the importance of keeping the Board aware of key performance indicators (KPIs) for research and keeping the OCS up to date. Identifies and presents opportunities and at executive level for consideration and takes proactive action to implement the decisions. A2. Working with external Partners A2. Stakeholders & Partnerships. Is unaware of the organisation’s immediate stakeholders and partnerships. Is aware of the organisation’s stakeholders and partnerships but does not understand their role Is aware of the organisation’s immediate stakeholders and partnerships and works effectively with them at a transactional level. Understands how own role and others fit within and complement the range of stakeholders and partnerships and the wider health research agenda (e.g. the NIHR and Health Research Authority). Is able to work strategically with the range of stakeholders and partnerships to deliver the organisation’s objectives.
A2.2 Research networks. Is unaware of research networks. Is aware of research networks but unclear of their role. Is aware of and understands the role of research networks and works with them to support researchers and to share information. Works collaboratively with research networks to implement new local initiatives. Takes an active leadership role in driving continuous improvement across research networks to which the organization belongs. A2.3 Industry. Is unaware of the difference between commercial and non-commercial research studies. Is aware of the difference between commercial and non- commercial research studies but is not part of their role. Facilitates the opening of commercial studies at sites. Takes part in feasibility and site selection visits. Facilitates the opening of and extends the oversight of commercial studies to ensure projects are recruiting to time and target. Applies proactive commercial insight to the delivery of R&D in the organisation and takes a strategic view on the importance of working with industry. A3. Working as a team to deliver successful research projects A3.1 Team working. Does not understand the role of team working. Understands the role of team working and is supportive of the team helping others where necessary. Understands the wider role of individuals in the team in working effectively and takes care to understand the roles and workloads of others. Actively manages team working and delegates responsibilities where appropriate. Ensures roles and responsibilities for research are clear within the team working environment and facilitates wider collaborative team working between R&D and other departments within own organization and bridging
organizational boundaries. A3.2 Good customer Service. Is unaware of the need for good customer service in the department. Understands the need for good customer service and applies it within role. Promotes and delivers a culture of good customer service across the team. Promotes good customer service and takes action where expectations fall. Is able to create, establish and monitor a good customer service culture in the department and wider stakeholder and partnerships. A3.3 Standard Operating Procedures (SOPs). Is unaware of SOPs in the office. Is aware of the SOPs that are relevant to their role but does not understand the wider implications. Uses SOPs that are relevant to their post, can train others in their use and is proactive in identifying any changes required. Has a full understanding of all SOPs in the department and any updating required and can train others in their use. Reviews and challenges SOPs on local and national merit. A3.4 Role of service support departments. Is unaware of the role of service support departments. Is aware of the role of service support departments in the delivery of research. Is aware of and ensures investigators and other users are aware of the role of service support departments in their research. Uses early assessment tools (e.g. the Research Support Service Framework planning tool). Works with investigators and service support departments from an early point to ensure research gets undertaken and delivered effectively. Engages with support departments to ensure research is appropriately supported and delivered at a strategic level. Takes remedial actions when necessary.
B. Supporting research projects throughout their lifecycle and managing research delivery B1 Supporting development of new studies – early stages B1.1 Protocol advice. Is unaware of the purpose of a protocol. Is aware of the purpose of a protocol but unable to advise on content. Understands the importance of a robust protocol. Can signpost researchers to research design and other support services. Liaises with the NIHR Research Design Service or other sources of advice and researcher to help ensure a robust protocol is developed. Provides advice to researchers on research methodology and protocol design. B1.2 Sponsorship decisions. Is unaware that decisions are made around sponsorship. Is aware of the information required in deciding to sponsor but is not part of their role. Is able to advise and explain to researchers the information required for the decision to sponsor. Is able to make the sponsorship decision for defined studies. Undertakes the decision on whether to sponsor a study and ensures that a mechanism for oversight of project is in place. B1.3 Intellectual Property (IP). Is unaware of the meaning of IP. Is aware of IP but does not understand its implications. Has a good understanding of IP. Is able to advise researchers on the organisation’s IP policy. Manages and negotiates research IP on behalf of the organisation. B1.4 Scientific Peer Review. Is unaware of the scientific requirements of a research project. Is aware that research needs to be safe and scientifically sound. Understands the role of peer review. Able to advise others on how to obtain peer review. Has a good working relationship with academic partners and actively promotes scientific review. B2 Supporting good financial and contractual management
B2.2 Funding for research. Is unaware of the need for research to be financed. Is that research needs to be financially supported but unsure of the mechanisms for this. Aware of the different funding avenues for commercial and studies. Understands the role of funding bodies, their requirements and the importance of appropriate research funding being available. Actively sources funding solutions locally and nationally for research. B2.3 Funding for research support. Is unaware of the various methods of financially supporting services. Is aware that research-related services can be supported from different sources but unsure which is appropriate. Is able to signpost researchers to relevant information on financial support for services. Is able to advise researchers on and NIHR support funding streams. Is able to explain and AcoRD and the NIHR funding streams including e.g. Research Capability Funding (RCF). B2.4 Costing a project. Is unaware of the importance of costing a research project. Is aware of relevant costing templates (e.g. NIHR) but does not use them every time. Has a good understanding of research NHS support costs and treatment costs. Can signpost people to the relevant member of staff/source of information. Is able to advise researchers and staff on costing a project. Can complete a simple costing template and negotiate realistic costs. Has a relationship with the service support departments. Ensures that are agreed processes in place for calculating and accepting project costs. Can negotiate on realistic costs with external partners/ commissioners. related
B3.2 Feasibility process. Is unaware of the need for project feasibility. Is aware that studies should be delivered well but not of the process for deciding the number of participants or resources. Understands the importance of feasibility and is able to deliver a robust method for deciding appropriate numbers of participants and resources. Is able to develop and deliver a robust feasibility review system. Engages with researchers on the importance of feasibility. Manages the feasibility process and ensures researchers are fully aware of their responsibilities around project delivery. B3.3 Proportionate Risk management. Is unaware that projects may have risks and that they need to be treated differently (proportionately). Is that projects may have risks that need to be treated differently (proportionately) but does not understand why. Understands what a proportionate risk management assessment is and their own role in making an assessment. Is able to lead a risk management assessment taking pragmatic actions and escalating concerns based upon the results. Is able to advise on legislation and risk and is able to manage study risks proportionately. B3.4 Project recruitment strategy. Is unaware of the need to develop recruitment strategies. Is aware that there is a different recruitment strategy and recruitment process for every study. Understands what can prevent or improve recruitment and can advise on avoiding pitfalls. Is able to explore options with research team and collectively decide on best recruitment strategy. Promotes the development of recruitment strategies.
B4. Supporting Research Study Management and Delivery B4.1. Research study set-up. Is unaware of what needs to be in place before a research study can start recruiting. Is aware of what needs to be in place before recruitment can start. Is able to advise researchers on what needs to be in place before recruitment can start. Is able to work with researchers to ensure that set up processes are completed in a timely way and allow a prompt start to recruitment. Establishes a system which ensures prompt study set up (post approval) and research team readiness to start recruitment. B4.2 First patient first visit metric. Is unaware of the time within which the first patient should be recruited. Is aware of the first patient metric but is not part of their role. Is able to remind and advise researchers on how to ensure patients are available to a study through robust feasibility. Is able to engage with the research team to ensure patients are available and meet the study criteria. Reports on first patient metric results. Establishes a system for recording and reporting the first patient into a study. Delegates the delivery of the system. B4.3 Meeting the NIHR metrics and contract benchmarks. Is unaware of the NIHR metrics and contract benchmarks. Is aware of the NIHR metrics and contract benchmark requirements at team level but not of any wider implications. Is aware of the NIHR metrics and contract benchmark requirements and their wider importance and impact and is able to advise others. Is able to implement processes and solutions that allow the organisation and investigators to meet the NIHR metrics and contract benchmark requirements. Works with senior staff to develop the strategy to meet the NIHR metrics and contract benchmark requirements and communicates the impact of metrics on the organisation.
B4.4 internal key performance indicators (KPIs) to monitor performance. Is unaware of the purpose and usage of KPIs. Is aware of KPIs but is not involved in their usage. Is of KPIs and uses them at team level to monitor performance. Develops KPIs to report to senior managers on performance. Develops and oversees KPIs and local strategy to ensure performance is monitored and reported to the chief executive/Board. B4.5 Supporting research delivery. Is unaware that researchers need to be supported in order to deliver the objectives of the research. Is of the need to support researchers to meet the objectives and metrics but not the mechanism for doing so. Understands the importance of supporting research, study recruitment and delivery. Monitors recruitment and escalates concerns. Acts on escalated concerns about delivery and performance and is able to support research teams in developing remedial action plans. Takes an overview of successful and unsuccessful studies and leads on determining the future of those research projects. B4.6 Research management advice for all types of research in which the organisation[s] participate. Is unaware of the requirements of a researcher facing role. Is able to give signposting advice to senior R&D colleagues or to service departments providing support. Is able to provide advice to research teams on good research practice and responsibilities, referring to study protocols and contractual agreements when necessary. Manages the overall delivery of research advice for the organisation. Promotes a holistic view of research and ensures the team has the skills and abilities to support research management. B4.7 Internal and external auditing/monitoring requirements. Is unaware of the need for and learning from robust auditing and monitoring of work Is that regular auditing and monitoring checks need to be carried out but does not understand why. Understands the reasons and information required for audit and monitoring and their role. Is able to implement and advise others on audit and monitoring systems. Establishes an auditing and monitoring system and report on the system outputs to assure key stakeholders of robust governance.
C1.4 Regulation and Legislation. Is unaware of the regulations and legislation that apply to research. Is aware that there are regulations and legislation that apply to research but cannot describe the requirements in general terms. Is aware of the need for legal and regulatory compliance (in particular CTIMPs, HTA, DPA, role of Caldicott guardian, MCA, IRMER and ARSAC) and is able to describe in broad terms what is required. Is able to apply the appropriate regulations and legislation pragmatically and proportionately to their work. Advises others on appropriate legislation and regulations applicable to their research and is confident in challenging inappropriate or unnecessary application. C1.5 Awareness of Regulatory Bodies in research. Is unaware of the existence of regulatory bodies. Is aware of regulatory bodies but not what they do and/or why. Is of regulatory bodies and their role. Understands the role of regulatory bodies, how applications are made and the requirements for approval. effectively with regulatory bodies including ethics and MHRA, is confident in understanding their requirements and roles and is able to advise staff appropriately. C1.6 Research Management and Governance systems (IRAS, CSP, NIHR Portal, local research management system). Is unaware of the research management and governance systems and databases used by R&D. Uses research management and governance systems within their role. Uses research management and governance systems pragmatically and proportionately within their role and can run reports from the systems. Understands research management and governance systems and can explain their use to others. Fully understands and actively promotes the use of research management and governance systems and explores their strategic use in supporting the management of research activity and reporting metrics.
C1.7 Research in the NHS – HR Good Practice Resource Pack (Research Passport System). Is unaware of the HR Good Practice Resource Pack. Is aware of the HR Good Practice but is not part of their role. Is able to operate the HR Good Practice Resource Pack system effectively and is able to escalate issues where necessary. Is able to advise and guide others on all aspects of the HR Good Practice Resource Pack. Deals with escalated problems associated with wider HR contractual processes. C2. Understanding the principles of Good Clinical Practice and Good Research Practice within R&D C2.1 Good Clinical Practice (GCP) and good research practice. Is unaware of the principles and requirements of GCP and good research practice.. Is of the principles and requirements of GCP and good research practice but does not understand their application. Understands the principles and requirements of GCP and good research practice and how they apply to different studies i.e. GCP is a legal requirement for regulated clinical trials. Understands all the principles and requirements of GCP and good research practice and promotes training and adherence as applicable. Challenges poor practice according to GCP and good research practice principles and requirements and recommends and secures the necessary improvement. C2.2 Adverse Event Reporting. Is unaware of adverse event reporting. Is aware of adverse event reporting but unsure of the process. Is aware of adverse event reporting and able to handle basic queries about the reporting of adverse events. Is able to handle queries about the reporting of adverse events and can administer the process for reporting adverse events. Acts and advises on the process and requirements for adverse event reporting. C2.3 Breaches of Good Clinical Practice (GCP). Is unaware of GCP. Is aware of GCP but unsure of the process relating to breaches. Is of GCP and able to handle queries about the reporting of GCP breaches. Is able to handle queries about the reporting of GCP breaches and can administer the process Is able to act and advise on the requirements of reporting GCP breaches and can secure the necessary improvement.
for reporting GCP breaches. C2.4 Training for researchers. Is unaware of the different training requirements for different types of research studies. Is that different types of training requirements may be needed but is unsure about the detail. Is able to identify different training requirements for different of research studies and can recommend options. Is able to promote appropriate training and ensure its delivery for appropriate staff. Is able to provide advice on, source and/or deliver training on good research practice. C3 Understanding Research Responsibilities and C3.1 & Responsibilities of Sponsors and Hosts. Is unaware of the and responsibilities of sponsors and hosts. Is aware of the roles and responsibilities of sponsor and hosts and that they are different but does not apply them in their role. Understands the roles and responsibilities of their organisation as a sponsor and/or host and is able to apply them to their role. Is able to advise others on the and responsibilities of sponsor and hosts. Is confident in challenging inappropriate delegation of roles and responsibilities and any breaches of sponsor and host roles and responsibilities.