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. See Research Compliance Team’ CRCT ‘Clinical A Clinical Trial of an Investigational Medicinal Product CTOC See: Trials Oversight Committee’ ‘Clinical A trial for which the overall study management or the majority of study CTU managed study management duties has been delegated to the CTU on behalf of a Sponsor. Examples include all or most of the activities of Registration, Site Initiation, Monitoring, IMP supply, Pharmacovigilance, Data Management and Statistical Analysis. Good Clinical Practice guidelines GCP College of Medical and Dental Sciences MDS Medicines and Healthcare products Regulatory Agency; the Competent MHRA Authority in the UK The person responsible for the conduct of the clinical at a trial site. If a Principal trial is conducted by a team of individuals at a trial site, the principal Investigator investigator is the leader responsible for the team and may be called the Principal Investigator. See Management System’ QMS ‘Quality A Quality Management System (QMS) is a system that includes procedures Quality Management and policies to describe how certain tasks should be performed and that System encapsulate any standards and/or regulatory requirements that may apply to those tasks. By adhering to the Quality Management System, the user and the UoB will be assured that applicable regulations are adhered to. See Governance Team’ RGT ‘Research Research The Research Governance Team is part of the Research Governance and Ethics Team and is responsible for confirmation of Sponsorship on behalf of Governance Team the UoB, signing-off any applications for approval/authorisation as Sponsor representative, issuing trial specific template Site Agreements, and for maintaining Sponsor oversight. See Form’ SAF ‘Self-Assessment UoB Ethical Review of Research Self-Assessment Form Self-Assessment Form
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. CRCT See ‘Clinical Research Compliance Team’ A Clinical Trial of an Investigational Medicinal Product CTOC See: ‘Clinical Trials Oversight Committee’ CTU managed study A for which the overall study management or the majority of study management duties has been delegated to the CTU on behalf of a Sponsor. Examples include all or most of the activities of Registration, Site Initiation, Monitoring, IMP supply, Pharmacovigilance, Data Management and Statistical Analysis. GCP Good Clinical Practice guidelines MDS College of Medical and Dental Sciences MHRA Medicines and Healthcare products Regulatory Agency; the Competent Authority in the UK Principal Investigator The person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the principal investigator is the leader responsible for the team and may be called the Principal Investigator. QMS See ‘Quality Management System’ Quality Management System A Quality Management System (QMS) is a system that includes procedures and policies to describe how certain tasks should be performed and that encapsulate any standards and/or regulatory requirements that may apply to those tasks. By adhering to the Quality Management System, the user and the UoB will be assured that applicable regulations are adhered to. RGT See ‘Research Governance Team’ Research Governance Team The Research Governance Team is part of the Research Governance and Ethics Team and is responsible for confirmation of Sponsorship on behalf of the UoB, signing-off any applications for approval/authorisation as Sponsor representative, issuing trial specific template Site Agreements, and for maintaining Sponsor oversight. SAF See ‘Self-Assessment Form’ Self-Assessment Form UoB Ethical Review of Research Self-Assessment Form
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