About PennChart

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Epic for Researchers

        External Monitor Access Form 

 

PennChart and 21 CFR Part 11

         Research Study Team Additions  


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@pobox.upenn.edu

External Monitor Access Form: 

You must be designated as a manager or physician in Lawson to complete the access request. The process for new auditor requests and renewing auditors has been revised as of 9/30/2016.  The new forms and process are outlined as follows:

  1. Manager emails agreement titled “Epic Link Conditions for Auditors and Reviewers” above to the auditor for him/her to complete and return to the manager.
  2. Manager should ask the Research team to provide a list of patients the auditor will review. This list should be emailed to the manager as an Excel file containing patient names and one or both of MRN, date of birth and the research protocol number (IRB Number).
  3. Manager completes the “Epic Link Auditor Account Request Form for Managers” above for Auditor/Reviewer Accounts.
  4. Once the Conditions agreement, Account Request Form and patient list (should be provided) are completed and received by manager, the manager should email these three documents to the Service Desk at HelpDeskSupport@uphs.upenn.edu.
  5. For renewal requests: Manager should complete the “Epic Link Auditor Account Request Form for Managers” and indicate beside “Type of Request” that the request is a Renewal Request (by checking appropriate box). Manager should then forward the form to the Service Desk at the email address above, attaching a copy of the original request form (if available).

For support or questions, call 215-662-7474 or email HelpDeskSupport@uphs.upenn.edu.

For site to access Electronic Medical Records — click here and login with your credentials.

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

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Add personnel to PennChart Research Studies Record

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 survey.

If 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 Workflow course in order to be added to the study team record in PennChart.

All personnel change requests will be communicated to your Business Administrator.

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.

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