C. Understanding Governance and Good Practice for NHS Research (national) C1. Understanding and assessing the regulatory and legislative compliance of a C1.1 Complying with Is unaware of the Is aware of the RGF Understands the sections Understands how the Advises others on the the Research Research but cannot describe of the RGF that are framework applies to content and application Governance Governance its purpose. appropriate to their role. what they do and can of the RGF. Framework. Framework (RGF). relate it to the role of others in the team. C1.2 NHS local decision Is unaware of the Is aware of their role Deals with queries relating Can identify and handle Manages the decision process. local decision in the local decision to their role only but queries relating to their process as a whole, process required process but cannot knows who in the role, understand wider ensuring it is before a research describe what others department deals with queries and issues and proportionate to risk and project can proceed do. other aspects of a study effectively resolve issues seeks continuous in the organisation. and can signpost people in the decision process improvement and effectively. where required. simplification. C1.3 Regulatory Is unable to advise Is aware of the Is able to advise and assist Is able to develop Ensures the team submissions. or assist with process for regulatory researchers with the training and support for supports researchers in regulatory submission. Is unable completion of regulatory researchers on the all aspects of the submissions. to provide assistance submissions. regulatory submission regulatory submission but can signpost process. process. people to help.
C. Understanding Governance and Good Practice for NHS Research (national) C1. Understanding and assessing the regulatory and legislative compliance of a C1.1 Complying with the Research Governance Framework. Is unaware of the Research Governance Framework (RGF). Is aware of the RGF but cannot describe its purpose. Understands the sections of the RGF that are appropriate to their role. Understands how the framework applies to what they do and can relate it to the role of others in the team. Advises others on the content and application of the RGF. C1.2 NHS local decision process. Is unaware of the local decision process required before a research project can proceed in the organisation. Is aware of their role in the local decision process but cannot describe what others do. Deals with queries relating to their role only but knows who in the department deals with other aspects of a study and can signpost people effectively. Can identify and handle queries relating to their role, understand wider queries and issues and effectively resolve issues in the decision process where required. Manages the decision process as a whole, ensuring it is proportionate to risk and seeks continuous improvement and simplification. C1.3 Regulatory submissions. Is unable to advise or assist with regulatory submissions. Is aware of the process for regulatory submission. Is unable to provide assistance but can signpost people to help. Is able to advise and assist researchers with the completion of regulatory submissions. Is able to develop training and support for researchers on the regulatory submission process. Ensures the team supports researchers in all aspects of the regulatory submission process.