Leveraging online technology for purposes of remote monitoring throughout the protocol lifecycle Dee Blumberg, Donna Brown, Ashley Case, Kayla Daniels,

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Presentation transcript:

Leveraging online technology for purposes of remote monitoring throughout the protocol lifecycle Dee Blumberg, Donna Brown, Ashley Case, Kayla Daniels, Anne Hoehn, Oscar Moreno May 15, 2016 Society for Clinical Trials, 37th Annual Meeting

Perspective on Monitoring Evoluation of biomedical research Paper-based data collection Monitor on site to evaluate study status Months before data could be reviewed Retrospective

Transition Electronic data collection Monitor on site to evaluate study status Data can be reviewed real-time Prospective Decades of infrastructure built around paper systems

Distributed Monitoring Effort Philosophy of team based monitoring support Strategize on-site activities for highest-risk activities Remote assessment with targeted follow-up Programmatic analysis of data Endpoints, safety, protocol adherence, data quality, monitoring metrics Utilize technology to see facilities and staff from afar Build in contingencies

Workshop Overview Remote Site Initiation Remote Consent Form Monitoring Protocol Deviation Monitoring AE Monitoring Integrity Checks Monitoring Status Reports Remote Site Close Out Visits Closing Remarks, Questions, Comments