Office of Clinical Research

• PennChart
• About PennChart

About PennChart

Click to go to each section:

	Epic for Researchers	Research Study Team Additions
	PennChart and 21 CFR Part 11	Register a New Subject in PennChart
	External Monitor/Auditor/Inspector Access	Research Access for Non-Penn users/ collaborators

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:
   • 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
3. The Help Desk sends an email to the external monitor/auditor/inspector with instructions on how to log in. 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 email psom-ocrfin@pobox.upenn.edu

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.

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) team at EMPITeam@uphs.upenn.edu .

Access for Non-Penn Users (for Research workflows only)

Purpose and current process as of January 2020

This workflow should not to be confused with External Monitor/ Auditor/ Inspector Access.

Penn Medicine physicians and faculty collaborate often with non- Penn Medicine institutions in conducting clinical research studies and clinical trials. Access to patient protected health information (PHI) at times is crucial for the regular conduct of these trials (including but not limited to maintaining safety of patients in trials, recruitment of Penn Medicine patients into trials).

In this context, Penn Medicine refers to the covered entity (UPHS and PSOM), all other UPenn entities, including the School of Nursing, Wharton, School of Engineering, etc. are considered 3^rd parties, and fall under this process of access for non-Penn users.

The following process has been developed in collaboration with various Penn Medicine stakeholders (Office of Audit, Compliance and Privacy), Penn Medicine Information Systems (IS), Office of Clinical Research and the Institutional Review Board (IRB), with the goal of easing operational workflow for Penn Medicine clinical research teams and their collaborators.

Information that will be considered at the time of reviewing the request for access:

1. A Penn sponsor for the request. “Sponsor” must be a Penn Medicine investigator, faculty, collaborating Penn research department’s business administrator (BA). The “sponsor” is a Penn Medicine employee responsible for maintenance of the user’s access (i.e. renewal requests, assigning start and end dates for access) and would be the primary contact for the Office of Clinical Research and Penn Medicine IS in case of issues. Refer above for who is considered Penn Medicine under "covered entity"
   • If you do NOT have a “sponsor” as defined above, do NOT proceed further. Email OCR Operations at psom-ocrops@pobox.upenn.edu (click email to populate template)
2. The user should be HIPAA trained and sign the Penn Medicine Confidentiality Statement, and commitment that Penn patient data is not taken “off- site”.
3. Penn IS will apply least privilege to determine if PennChart access is truly necessary or if Penn Data Warehouse reports would suffice.
4. Penn IRB approval is in place for requested research study.

Requests will be processed on a first-come-first-serve basis. Once PennChart access is obtained, if the user does not log into PennChart for 90 days, the account is locked out or inactivated. A helpdesk ticket may be submitted to request that your access is reinstated (link requires UPHS remote login)

Use the steps below to guide you through access request:

1. New access requests (separate forms must be submitted for each user)

1. Sponsor must fill out the Penn Medicine details required for access request (non-Penn Research users only)
2. New user must review and sign (wet ink) the Penn Medicine Confidentiality Agreement 
3. Email all above required documents to psom-ocrops@pobox.upenn.edu  with Subject Line: “PennChart Access Request for non-Penn user”
4. Processing and approval of the request may take 3 to 5 business days. OCR may contact the Sponsor to obtain more information about the request.
5. Sponsor must request a PennKey if the user does not have one. https://pennkeysupport.upenn.edu/help
6.  User must then log into Penn Medicine’s Learning Portal and complete HIPAA training (also called Protecting Patient Information).
7. User must then complete in-person PennChart training per instructions listed on the OCR website: https://www.med.upenn.edu/ocr/training-and-resources.html
8. Once user completes training, Sponsor must work with the department’s designated UPHS Lawson Manager to submit a PennChart access request ticket.
9. Once UPHS credentials are obtained please use the PennChart Research tipsheets and guidance listed here for ongoing needs: https://www.med.upenn.edu/ocr/training-and-resources.html

1. Renewal of existing access (separate forms must be submitted for each user)

1. Sponsor must fill out the “Penn Medicine details required for access request (non-Penn Research users only” 
2. New user must review and sign (wet ink) the Penn Medicine Confidentiality Agreement 
3. Complete the latest HIPAA Training ( Search Knowledge Link for Protecting Patient Information or HIPAA)
4. Email all above required documents to psom-ocrops@pobox.upenn.edu with Subject Line: PennChart Access Request for non-Penn user”
5. Processing and approval of the request may take 3 to 5 business days. OCR may contact the Sponsor to provide more information about the request.

Once approval is obtained, continue to use the system with established UPHS credentials. NOTE: External users are provisioned with PennChart access for a maximum time of a year. Access needs to be renewed annually. User must work with Sponsor and UPHS Lawson Manager to request extension for access.

Learn more about PennChart Research.

 

 

Top