Abbreviations and Definitions: Term Description Administration of Radioactive Substances Advisory Committee Birmingham region Research Training Collaborative BRTC The BRTC supports the delivery of high quality clinical research in its member organisations by providing access to research related training activities and a communication forum whereby learning resources and local events can be shared. The person who takes overall responsibility for the design, conduct and Chief Investigator reporting of a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary responsibility for the design, conduct and reporting of the study, whether or not that person is an investigator at any particular site. Note that for CTIMPs the Chief Investigator must be an authorised health professional. Competent Authority CA See Investigator’ CI ‘Chief Any health related research on humans. Clinical research Any health related research study on humans. This includes: Clinical study Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology Study involving qualitative methods only Study limited to working with human tissue samples (or other human biological samples) and data (specific project only) Study limited to working with data (specific project only) For clinical trials using an Investigational Medicinal Product: Clinical trial Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy. For all other clinical trials: Prospective biomedical research on human subjects that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions. Examples include devices, surgery and radiotherapy trials. The Clinical Trials Oversight Committee (CTOC) provides sponsor oversight Clinical Trials of UoB’s portfolio of Clinical Trials of Investigational Medicinal Products Oversight (CTIMPs). The CTOC also provides a means for the Research Governance Committee Team to obtain expert advice relating to non-CTIMPs. The CTOC reports to the Pro-Vice Chancellor for Research & Knowledge Transfer through the University Research Governance and Ethics Group, and to the University of Birmingham Internal Audit Office.
Abbreviations and Definitions: Term Description Administration of Radioactive Substances Advisory Committee BRTC Birmingham region Research Training Collaborative The BRTC supports the delivery of high quality clinical research in its member organisations by providing access to research related training activities and a communication forum whereby learning resources and local events can be shared. Chief Investigator The person who takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary responsibility for the design, conduct and reporting of the study, whether or not that person is an investigator at any particular site. Note that for CTIMPs the Chief Investigator must be an authorised health professional. CA Competent Authority CI See ‘Chief Investigator’ Clinical research Any health related research on humans. Clinical study Any health related research study on humans. This includes: Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology Study involving qualitative methods only Study limited to working with human tissue samples (or other human biological samples) and data (specific project only) Study limited to working with data (specific project only) Clinical trial For clinical trials using an Investigational Medicinal Product: Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy. For all other clinical trials: Prospective biomedical research on human subjects that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions. Examples include devices, surgery and radiotherapy trials. Clinical Trials Oversight Committee The Clinical Trials Oversight Committee (CTOC) provides sponsor oversight of UoB’s portfolio of Clinical Trials of Investigational Medicinal Products (CTIMPs). The CTOC also provides a means for the Research Governance Team to obtain expert advice relating to non-CTIMPs. The CTOC reports to the Pro-Vice Chancellor for Research & Knowledge Transfer through the University Research Governance and Ethics Group, and to the University of Birmingham Internal Audit Office.
UoB-CLN-CTM-SOP-001%20Clinical%20Trial%20Management%20v%203.0%20(EAv2.0)%20for%20web.docx