Data safety and monitoring for research involving remote health monitoring

Abstract

Investigators conducting research involving human subjects are obligated to safeguard the wellbeing of the study participants. Other than requiring investigators to establish procedures for ongoing monitoring and reporting of adverse events, federal regulations do not dictate how human subject safety should be ensured. A variety of data safety monitoring (DSM) procedures may be acceptable depending on the nature, size, and complexity of the study. However, practical guidance for establishing and implementing appropriate DSM plans for such studies are lacking. In this article, we provide a review of the DSM considerations associated with monitoring health remotely and describe the Pocket Personal Assistant for Tracking Health project as an exemplar for how to develop effective DSM plans for research that captures clinical data using remote health-monitoring devices. Protecting the safety and welfare of participants is one of the most important mandates for research involving human subjects. Investigators have an ethical and scientific responsibility to monitor the safety of research participants. Investigators typically fulfill this responsibility by monitoring and reporting adverse events.

Figures

Fig. 1.

Sample Personal Assistant for Tracking Health (Pocket PATH)™ screen for data entering.

Fig. 2.

Sample Pocket PATH® screen of blood pressure graph.

Fig. 3.

Main screen of Pocket PATH® data safety monitoring Web site.

Fig. 4.

Algorithm for coding response to critical values. TPMS, Transplant Patient Management System.