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                    "text": "• Management of Intellectual Property"
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                    "text": "Integrity in Research"
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                    "text": "• Consent for use of clinical samples and data in research."
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            "text": "These policies are underpinned by a suite of Standard Operating Procedures (SOPs) within R&D governance. Policies and SOPs are updated in response to national and local developments. The OUH R&D Governance team conducts a wide variety of activities, which are summarised below."
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            "text": "17.11. GCP Monitoring. The purpose of monitoring is to ensure that the safety of participants is assured; that the trial results will be credible and accurate and that the trial is conducted in accordance with the protocol and regulatory frameworks. The R&D Governance team undertakes monitoring visits for each OUH-sponsored regulated trial."
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            "text": "17.12. Formal auditing of compliance. An audit is part of implementing quality assurance. It is independent and separate from routine monitoring or quality control functions. The purpose of an audit is to evaluate a system(s) or trial conduct and compliance with the protocol, SOPs, Good Clinical Practice (GCP), and the applicable regulatory requirements. Where OUH is hosting research with an external Sponsor, such trials may be audited by the R&D Governance team, which now has three lead auditors. These trials are selected through a risk-based approach. Due to other priorities no audits were conducted by the R&D Governance team during 2025-26, however 3 studies have been highlighted for audits during the next year."
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            "text": "17.13. Compliance checks. The R&D Governance team also routinely undertakes assessment of compliance with various aspects of clinical research; primarily focussing on informed consent and safety reporting. These brief checks are of great value for oversight of compliance and as they are less resource intensive than formal audit, a greater number of studies can be covered. During 2025-2026 29 informed consent and 4 safety compliance checks have been completed. The findings were fed back to the relevant teams. They will be summarised and shared in an anonymised format with all the research delivery teams working across OUH, to help improve quality and promote best practice."
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            "text": "17.14. To support investigators and research teams, the R&D Governance team and Head of NMAHP Clinical Research Delivery formally facilitate regulatory inspections of research conduct at OUH."
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            "text": "Research & Development Governance and Performance Report 2025-26",
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            "text": "Page 34 of 38",
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