There is essentially no formal evaluation research that demonstrates the impact of nurses as study coordinators and caregivers in a research setting on specific quality, safety, or efficiency outcomes. Across the 30year history of writing on this topic, there are themes
that have emerged anecdotally as outcomes affected by clinical research nurses, including early assessment of adverse events, subject identification and recruitment, subject education, study management to improve efficiency, improved subject retention, better adherence of study subjects to treatment regimen, extension of principal investigator (PI) effectiveness and availability (serving as PI-extender), maintenance of adequate informed consent, alerting research team
to protocol violations, adapting clinical technology to support study implementation, training clinical staff, and facilitating the management and analysis of data.
There is essentially no formal evaluation research that demonstrates the impact of nurses as study coordinators and caregivers in a research setting on specific quality, safety, or efficiency outcomes. Across the 30year history of writing on this topic, there are themesthat have emerged anecdotally as outcomes affected by clinical research nurses, including early assessment of adverse events, subject identification and recruitment, subject education, study management to improve efficiency, improved subject retention, better adherence of study subjects to treatment regimen, extension of principal investigator (PI) effectiveness and availability (serving as PI-extender), maintenance of adequate informed consent, alerting research teamto protocol violations, adapting clinical technology to support study implementation, training clinical staff, and facilitating the management and analysis of data.
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