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Protection by Exclusion? Capacity as a Gatekeeper to Research
Type: Blog
Author: Victoria Shepherd, Richard Griffith, Mark Sheehan, Fiona Wood, Kerenza Hood
Keywords: mental incapacity, mental capacity, consent, exclusion, access, protection
Link Reference: 637
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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 deviation tracking log
Type: Example Form
Author: University of Leicester, University of Loughborough & University Hospitals of Leicester NHS Trust Joint Research Office
Keywords: Protocol, deviation, log
Link Reference: 289
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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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Protocol deviations, non compliance and serious breaches
Type: Example SOP
Author: NOCLOR Research Support
Keywords: Protocol, deviation, breach, serious breach, non compliance
Link Reference: 292
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