EPIC for Researchers
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.Please email your sponsor's EHR/EMR questionnaire to Penn Medicine's DART team's Service Information Officer, Vince Frangiosa.
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 .
If you need access to any of the health system’s clinical systems, a UPHS Sponsor will need to submit a Non-Payroll Resource request within PennforPeople. The UPHS sponsor should also request access to Knowledge Link on the same form.
Once the new hire has a health system profile, the UPHS Sponsor can request training and access to PennChart. To submit the request, the UPHS Sponsor will need the new hire’s Name, DOB and Penn ID.
The PennChart access request form does not live within PfP. It is a separate form that needs to be submitted. Please do not submit the form prior to re-registering the new hire for the required PennChart education in Knowledge Link. PennChart access request form: PennChart Access Request Form
We recommend you log into KnowledgeLink with your PennKey before clicking on any of the links. Completion of the training will be recorded in your KnowledgeLink learning history.
HIPAA Training: All PennChart Users need HIPAA Training: Protecting Patient Information (HIPAA)
View Only Access: For View Only access to PennChart (online course): PennChart View Only
Research Coordinator Access: For access to perform research functions (documenting, associating patients to studies, linking encounters to studies, manage My Studies) you need to take two (2) virtual classes:
- Research Coordinator Class: PennChart Training for Research Coordinators· Prerequisite: You must complete the Slicer Dicer virtual training to attend the Research Coordinator class.
- Ambulatory training: If you have not already taken an ambulatory training class, recommended is: PennChart Training for Ambulatory Medical Assistants (MA) and Clinical Research Coordinators (CRC)
Research Billing Review Access: If you will be conducting research billing review, you also need to take the Research Biller Class: PennChart Training for Research Billers
Beacon Protocols: If you will be using Beacon Protocols, it is recommended that you also take: PennChart Training for Treatment Plans (Beacon) for Non-Oncology Providers
Research (investigational) medications may refer to any novel therapies (vaccines, biologics, drugs, elc) or commercially available medications ordered or administered as part of a research protocol.
- All research (investigational) medications for research participants being seen at Penn Medicine locations are to be electronically ordered via PennChart.
- All research (investigational) medications being administered to research participants at Penn Medicine locations are to be documented in PennChart.
- All research studies with research (investigational) medications ordered or administered as part of a research protocol must have a research study “RSH” record in PennChart.
The following are procedures for requesting research (investigational) medication build in PennChart:
Beacon Protocol Request:
Study team submits Protocol build request form* to PennChart Beacon team using the following link Beacon Protocol Build Request
Pharmacist submits a medication build request form to the Beacon Team using the following link Beacon or Research Medication Build Request.
*The applicable request form (Protocol Build Request or Investigational Medication Build Request) is included in the Athena ticket using the hyperlinks listed above.
Non-Beacon Medication Request:
Pharmacist or Study team submits a medication build request form* to the PennChart Research Team using the following link Beacon or Research Medication Build Request
*The applicable request form (Investigational Medication Build Request) is included in the Athena ticket using the hyperlink above.
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:
- Monitor/auditor/inspector’s completed Conditions of System Access for Auditors/Reviewer form
- Physician Link Account Request Form for Auditor/Reviewer Accounts
- 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.
- 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.
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 3rd 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:
- 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 email@example.com (click email to populate template)
- The user should be HIPAA trained and sign the Penn Medicine Confidentiality Statement, and commitment that Penn patient data is not taken “off- site”.
- Penn IS will apply least privilege to determine if PennChart access is truly necessary or if Penn Data Warehouse reports would suffice.
- 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:
- New access requests (separate forms must be submitted for each user)
- Sponsor must fill out the Penn Medicine details required for access request (non-Penn Research users only)
- New user must review and sign (wet ink) the Penn Medicine Confidentiality Agreement
- Email all above required documents to firstname.lastname@example.org with Subject Line: “PennChart Access Request for non-Penn user”
- 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.
- Sponsor must request a PennKey if the user does not have one. https://pennkeysupport.upenn.edu/help
- User must then log into Penn Medicine’s Learning Portal and complete HIPAA training (also called Protecting Patient Information).
- 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
- Once user completes training, Sponsor must work with the department’s designated UPHS Lawson Manager to submit a PennChart access request ticket.
- 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
- Renewal of existing access (separate forms must be submitted for each user)
- Sponsor must fill out the “Penn Medicine details required for access request (non-Penn Research users only”
- New user must review and sign (wet ink) the Penn Medicine Confidentiality Agreement
- Complete the latest HIPAA Training ( Search Knowledge Link for Protecting Patient Information or HIPAA)
- Email all above required documents to email@example.com with Subject Line: PennChart Access Request for non-Penn user”
- 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.
OCR Finance offers a range of services to assist investigators and research personnel with the pre-award submission process and the post-award management of industry-funded clinical trials. OCR offers budget creation and negotiation services; we will work with investigators and their study teams to develop budgets for clinical trials and negotiate terms with industry sponsors. Generally, budgets should be developed only after a coverage analysis has been approved, unless fully funded by the Sponsor.
The Budgeting Team Can Help
- Develop protocol-specific budgets and negotiate with sponsors to ensure adequate financial support
- Assist the PI in projecting the costs for investigator-initiated trials
- Ensure the use of standardized costs for research procedures and clinical trials across multiple programs
- Ensure that appropriate budget and payment terms are included within the clinical trial agreements
- Care Everywhere: Appropriate Use Guidance for Research
- Guidance for Suppressing Research Results from myPennMedicine
- Guidance for Blinded Studies and My Penn Medicine
- PennChart Privacy Discussion
- PennChart Pending Order for Investigational Product Video
InBasket Notification Tipsheets
Research Billing Tipsheets
- Research Professional Billing Escalation