In This Section      
 

Research Study Monitoring Enrollment

Johns Hopkins CareLink may be used to facilitate monitoring of Johns Hopkins research studies by study sponsors. It provides real-time web access for study monitors to review research study patients' clinical data. Permission for this access requires coordination and communication between the study monitor and the Johns Hopkins research study team being monitored as described below.

Study Monitors

Study monitors shall not attempt to request access to, or use CareLink without permission and oversight from a designated representative of the Johns Hopkins research study they wish to monitor. Study monitors must reach out to their contact(s) on the Johns Hopkins research study team to be enrolled in CareLink. The Johns Hopkins research study team will monitor your use of CareLink.

Study monitors are granted view-only access to a list of patients pre-populated in CareLink by the Johns Hopkins study team for monitoring. Study monitors will not have any capability to lookup other patients in the EMR besides those on the list.

Study monitors may view the full patient chart for any of the patients on their list. Study monitors will not receive any notifications of any patient activity; visits, admission, discharges, or otherwise. Study monitors will not have any ability to refer patients to others, share patient charts with others, or extract data from CareLink.

Research Study Team

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 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 will be denied if the above conditions aren't met.

To request access to CareLink for your study to be monitored, please refer to the Research Site Administrator Quick Start Guide on the Epic Training Portal for detailed instructions. This document also contains responsibilities of the study team and information on the use of CareLink.

IMPORTANT: This is a confidential document for internal use only by the Johns Hopkins study team, shall not be distributed to the study monitor or sponsor, and is only accessible while logged into the Johns Hopkins network with a valid JHED ID.

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. It also is only accessible while logged into the Johns Hopkins network with a valid JHED ID.