About PennChart

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Epic for Researchers

      Research Study Team Additions 

 

PennChart and 21 CFR Part 11

      Register a New Subject in PennChart   

 

External Monitor/Auditor/Inspector Access 

 

EPIC for Researchers

UPHS uses EPIC as the software for the outpatient electronic medical record system.  The EPIC clinical system is known as PennChart. More details available here.

The specific type of access that you will need in PennChart is contingent upon your role in clinical research study.  Please see below for the type of access that best fits your role and how to obtain this access.

Access to each of the following tutorials/trainings can be obtained through KnowledgeLink.

PennChart and 21 CFR Part 11:

Penn’s research community has had an increasing trend of sponsors asking about the Part 11 compliance of our EMR.

The attached guidance will be useful in providing a response to questions from sponsors regarding this issue. Please click here to review guidance. 

Please note: this document is Penn Key protected. If you are a non-Penn entity, and need to access this document, please contact the relevant research study team or OCR at 215-662-4484, Email: mdutt@upenn.edu

External Monitor/Auditor/Inspector 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:

  1. Coordinator sends the External monitor/auditor/inspector the Condition for System Access form to complete and return.
  2. 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:
  3. 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.
  4. 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.

For more information on Conditions of Clinical Systems Access for External Personnel, visit the Penn Manual.

Add personnel to PennChart Research Study Records

You are now able to request personnel updates to the PennChart research study record which provides the security to associate patients  and link encounters to that study. To add or remove study personnel to the PennChart record, please complete this RedCap surveyIf you need to add personnel to more than one protocol, please fill out a separate RedCap survey.

Please note: Study coordinators must have completed the PennChart Research Coordinator course in order to be added to the study team record in PennChart.

If you are a BA, your current RBA workflow will not change. If you need to add more than two coordinators to a study please use the RedCap survey to do so.

 
Register a New Subject in PennChart

This is typically done for subjects or patients that do not have an existing MRN in our PennChart system. In order to request a patient MRN, please fill out this form and email the form to the EMPI (Epic) and OCR teams at EMPITeam@uphs.upenn.edu and psom-ocr@pobox.upenn.edu.

Learn more about PennChart Research.

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