1. 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

2. 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

3. 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

4. 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

5. 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