Reference Safety Information (RSI) | ​The information contained in either an investigator's brochure or an approved Australian Product Information (or another country's equivalent) that contains the information used to determine what adverse reactions are to be considered 'expected adverse reactions' and on the frequency and nature of those adverse reactions. |
Regional Director (RD) | A person that has is a Regional Director, within WA Country Health Services (WACHS), with responsibility for the site(s) where the research project will be conducted. Responsible for reviewing the project to ensure that the services and resources are adequate to conduct the research project within the Region. |
Research | As defined in the Australian Code for the Responsible Conduct for Research: ...original investigation undertaken to gain knowledge, understanding and insight. As defined in the United Kingdom Research Assessment Exercise: … the invention and generation of ideas, images, performances, artefacts including design, where these lead to new or substantially improved insights; and the use of existing knowledge in experimental development to produce new or substantially improved materials, devices, products and processes, including design and construction. It excludes routine testing and routine analysis of materials, components and processes such as for the maintenance of national standards, as distinct from the development of new analytical techniques. It also excludes the development of teaching materials that do not embody original research. |
Research Department | The department in which the research project will be conducted i.e. the department which is spearheading the project at a site. |
Research Governance | ​A process used by an organisation for the oversight, assessment, authorisation and monitoring of research conducted at one or more of its sites or under its auspices. A research governance framework includes good research culture and practice, organisational strategy, role definition and accountabilities, risk, resource and financial assessment and management, compliance with legal, regulatory and contractual requirements, competencies and training of personnel, site assessment, scientific review, ethical review and approval, site authorisation, monitoring of research, and management of conflicts of interest, complaints and allegations of research misconduct. |
Research Governance Office (RG Office) | ​An office within a public health organisation established to undertake research governance on behalf of sites within the public health organisation. |
Research Governance Officer (RGO) | A person that has been appointed to an administrative position within a WA Health RG Office. This person is responsible for reviewing the forms and supporting documents related to governance applications and administers site authorisation documentation. The RGO provides recommendation for site authorisation to the CE or Delegate. |
Research Governance Service (RGS) | RGS supports the research governance framework for all human research conducted within WA Health or accessing WA Health participants, their tissue or data. The RGS is a centralised IT system for investigators, project members, sponsors, Hospital Administrators/sites, Human Research Ethics Committees & Research Governance Offices to complete, submit, administer, track and report on ethics and governance documentation throughout the lifecycle of a project, including authorisation, monitoring, closure and publications. |
Research Group Member (RGM) | ​This is default membership given to anyone invited to the project as a Project Member who has not been given a project specific role. Within RGS they can provide information and edit project forms and upload supporting documents to which the y are assigned according to their security and access rights. |
Review Decision Date | ​The date the HREC or RGO makes a decision on their review of the valid ethics or governance application respectively. |