Chart Access for Research Monitors
New electronic processes will also go into effect August 15th for research monitor-related access to IU Health systems.
To help facilitate monitor review of pertinent research information within the electronic medical record (EMR), IU Health will begin using a dynamic patient list created from information in PowerTrials that is already required for both patient safety and compliance. PowerTrials’ security configuration allows a view-only monitor workflow that restricts access to only charts of patients enrolled on the protocol to be monitored. These access requests will be granted for the life of the study. Please note that this new process replaces the existing paper research access requests. Users in existing monitor roles will be transitioned between August 15 and December 31, 2019.
When patient enrollment is tracked using PowerTrials, the Clinical Research: Auditor/Monitor role minimizes the impact of monitor site visits on ongoing activities. Without PowerTrials, more time intensive preparation and supervision of the visit is required. PowerTrials eliminates the need to manually create and maintain patient lists and also removes the need to constantly supervise the monitor’s use of EMR to prevent access to unauthorized patient charts.