Following the release of the 2011 draft Guidance for Industry Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring, sponsors are looking for more ways to implement this approach that will mutually benefit the sites and sponsors without jeopardizing the safety of the subjects and the quality of the data. One suggestion that has been noted in the field leans toward hospitals allowing monitors access to electronic medical records (EMR) to monitor remotely.
Listed are the Top 5 Reasons that sponsors may want to pursue this route for monitoring and how hospitals/investigational sites can also reap the benefits:
- Increased efficiency - This is a win-win for the coordinators and monitors. Monitors can focus their time on-site for monitoring tasks that cannot be done remotely such as product accountability and will require less time from the coordinator while on site. Monitoring visits could go from frequent, multiple day visits to periodic ½ day visits. Coordinators won’t dread monitoring visits and view them as time monopolizers.
- Improved productivity - Monitors take up coordinators’ valuable time. The more time that a coordinator spends with a monitor is less time that could be spent recruiting and enrolling subjects into the sponsor’s studies. Similarly for monitors, less time spent on traveling could be funneled into more time monitoring remotely.
- More cost effective - The more remote monitoring a sponsor can conduct, the less the monitors are on the road spending sponsor’s dollars on travel.
- Fewer monitoring visits - Keeping monitors in the office more and on the road less will significantly decrease monitor burnout and turnover. A site will be more likely to have 1 or 2 monitors for the life of a study at their site rather than 5 or 6. Not only is this helpful for the monitors, but also beneficial for the sponsor. Less time and cost is spent on-boarding and training new monitors. A site’s burden is decreased by not having to familiarize new monitors with the sites standard operating procedures.
- Real time-identification of non-compliances and adverse events - Good monitors are aware of their sites patient follow-up schedules. Monitors can assist sites in identifying non-compliances and adverse events by reviewing the EMR shortly after visits happen. This can decrease the amount of systematic errors that are most often identified during on-site visits after several repeating errors.
Do you know any hospitals that are allowing monitors access to EMR for remote monitoring? Can you identify reasons that hospitals may be hesitant to allow such access? What other challenges might sponsors face in attempts of implementing this practice to align with a risk-based monitoring approach?
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