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Our resources and outputs, enabling
health and care research in the UK

Resource Exchange

Search Category: Monitoring

Code of Conduct For Clinical Research Monitors and Auditors – Remote Access
Type: Example Tool
Author: Royal Free London NHS Foundation Trust
Keywords: Monitoring, audit, code, remote access, COVID-19, COVID
Link Reference: 3629
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Data sharing in clinical trials – practical guidance on anonymising trial datasets
Type: Article
Author: 
Keywords: data sharing, anonymisation, data sets. clinical trials data, data management
Additional Detail: Useful for Sponsors, CTUS and research teams when anonymising data sets for future use.
Link Reference: 594
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Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review.
Type: Paper
Author: Cragg WJ, Hurley C, Yorke-Edwards V, Stenning SP. Clinical Trials. February 2021.
Keywords: Monitoring, audit, code, remote access, COVID-19, COVID, Sponsorship, Sponsors
Link Reference: 10657
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External Monitoring Research Visits: Code of Conduct
Type: Example
Author: Cambridge University Hospitals NHS Trust/ Cambridge BRC
Keywords: Monitoring, COVID-19, external visitors, monitors, code of conduct
Link Reference: 2887
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Guidance for site study teams and sponsors for remote monitoring and source data verification within Barts Health NHS Trust
Type: Example Guidance
Author: Joint Research Management Office, Queen Mary University of London and Barts Health NHS Trust
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, remote monitoring, monitoring, SDV, IG
Link Reference: 2885
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Induction pack for PPI contributors on Trial Oversight Committees
Type: Tool
Author: MRC CTU at UCL
Keywords: PPI, induction, induction pack Trial oversight committees, Patient and Public Involvement
Link Reference: 692
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MHRA Blog: Sponsors Oversight Part 1
Type: Blog
Author: MHRA
Keywords: Sponsorship, oversight, audit, monitoring, quality, risk, sponsors, regulation, GCP, clinical trials
Link Reference: 660
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Monitoring & Oversight of Research Activity
Type: Example SOP
Author: University Hospitals Bristol NHS Foundation Trust
Keywords: Bristol, SOP, monitoring, oversight
Link Reference: 503
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Monitoring during COVID 19 at GSTFT.
Type: Example Guidance
Author: Guy’s & St Thomas’ NHS Foundation Trust
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, remote monitoring, re-start, restart
Link Reference: 2878
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Monitoring Plan template
Type: Example Form
Author: University Hospitals Leicester NHS Trust
Keywords: Leicester, monitoring, plan, template
Link Reference: 497
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Monitoring SOP
Type: Example SOP
Author: University Hospitals Leicester NHS Trust
Keywords: Leicester, SOP, management, monitoring
Link Reference: 500
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Monitoring strategy table
Type: Example Strategy
Author: University Hospitals Leicester NHS Trust
Keywords: Leicester, trial, monitoring, strategy, CTIMP
Link Reference: 498
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Monitoring Systems
Type: Paper
Author: NHS R&D Forum
Keywords: monitor, audit, quality
Link Reference: 502
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Monitoring visit report
Type: Example Form
Author: University Hospitals Leicester NHS Trust
Keywords: UHL, monitor, visit, template
Link Reference: 499
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Protocol Deviation Reporting: Cutting Through The Ambiguity
Type: Article
Author: Catherine Stewart, clinical sciences group lead, Pfizer, and Laura Galuchie, TransCelerate program lead, Merck
Keywords: protocol deviations, monitoring, integrity, safety, data, oversight, Sponsorship, GCP, ICH
Link Reference: 2830
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Protocol Deviations Toolkit
Type: Website resources
Author: Transcelerate
Keywords: protocol deviations, monitoring, integrity, safety, data, oversight, Sponsorship, GCP, ICH
Link Reference: 2819
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SOP: Remote Monitoring
Type: Example SOP
Author: Nottingham University Hospitals NHS Trust
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, remote monitoring
Additional Detail: Please note this is a DRAFT SOP at the time of publication
Link Reference: 2871
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Sponsor Monitoring guidelines:
Type: Example Guidance
Author: Royal Free London NHS Foundation Trust
Keywords: Monitoring, audit, code, remote access, COVID-19, COVID, Sponsorship, Sponsors
Link Reference: 3630
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Sponsor oversight, blog 2
Type: Blog
Author: MHRA
Keywords: Sponsorship, Sponsor, oversight, audit, monitoring, quality, risk, sponsors, regulation, GCP, clinical trials, CTIMPS
Link Reference: 695
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