Hopkins CareLink for Research Study Monitors is Now Available

After successful pilot testing, Hopkins CareLink is now available for research study teams to provide their study monitors with real-time web access to their participants’ clinical data.  Study monitors are able to review patients’ charts directly within CareLink since they are granted access to a list of the study participants which allows access to only those patients’ charts.

Study teams interested in using CareLink must first designate a person from their study to act as the CareLink site administrator. This person is responsible for setting up the research study site to be monitored as well as requesting access for monitors to use CareLink. It is also the responsibility of the site administrator to create the list of study patients that will be available for the monitors to review. For a comprehensive list of site administrator responsibilities and complete instructions on enrolling your study to use CareLink for study monitoring, please see http://www.hopkinsmedicine.org/CareLink/research-study-monitoring.html for full details.

Before requesting access to Hopkins CareLink the following qualifications must first be met:

  • Your research study must be maintained in CRMS (Clinical Research Management System) along with up to date patient statuses, in order to use CareLink for study monitoring.
  • One team member (research coordinator, research nurse, etc.) of the Johns Hopkins study being monitored, must be designated as the primary contact for the study monitor and as the CareLink site administrator for the study.
  • The site administrator must also be listed in CRMS as a member of the study team under one of the IRB approved roles for the study being monitored. They must already have completed training, have access to, and currently using Epic.

Requests by study teams to use CareLink for study monitoring must be denied if the above conditions aren’t met.

Study teams who have met the above conditions may refer to the Research Site Administrator Quick Start Guide on the Epic Training Portal for detailed instructions to request access to CareLink. Additionally, a Research Study Monitor Quick Start Guide is also available on the Epic Training Portal for the study team to download and give to the study monitor. It contains rules of the road for study monitors and information on their use of CareLink and also is only accessible while logged into the Johns Hopkins network with a valid JHED ID.