Monitoring

Internal Resources

Operations
Clinical Study Management
Monitoring

In light of current travel restrictions, and to limit traffic on campus and within the health system as much monitoring as can possible be conducted remotely should be done so in a remote manner. Below is the link to the PSOM SOP on conduction of remote monitoring visits by external monitors.

PSOM SOP 406

Additionally, here are some details to support remote monitoring on Penn’s campus:

Remote Access to the EMR: External Monitor/Auditor/Inspection Access to PennChart

For a coordinator to provide access for an external monitor/auditor/inspector to review patient records in PennChart, they use Physician link:

Coordinator sends the External monitor/auditor/inspector the Condition for System Access form to complete and return.
Coordinator opens an IS Help Desk ticket through the IS Self Service Portal or by calling (215) 662-7474. (You may need to login via “Two step verification”). Request to have a “Patient Group for external study monitor using physician link created” including:
- Name of the study
- Who needs access to the patient group (themselves, external monitor/auditor/inspector)
- Attach two forms:
  1. Monitor/auditor/inspector’s completed Conditions of System Access for Auditors/Reviewer form
  2. Physician Link Account Request Form for Auditor/Reviewer Accounts
The Help Desk sends an email to the external monitor/auditor/inspector with instructions to complete view only training and log in information. Once log in is provided to external monitor/auditor/inspector, they log in through the Physician Link web site.
CRC logs into PennChart, runs Find Patients Associated with my Studies report. Select patients to release and clicks “Release to Study Monitor” button. Complete pop up adding:
- Study name
- Patient group (provided by the Help Desk)
- Start and End dates – this controls the length of time the monitor/auditor/inspector has access to the records. Their access will continue until the end date.

Remote Access to regulatory site files: Determine as a site which remote option will be used to support the conduct of your trial.