1. Research and Reporting
Jim Oates, MD
Informatics Medical Director of Research and Reporting
September 15, 2016
Epic Research Team
Les Lenert, CRIO
Melissa Habrat – Program Manager
Bob Warren, CMIO
Signe Denmark, Research Opportunities & Collaborations

2. Objectives – be familiar with
What types of data are available from Epic versus the Clinical Data Warehouse
Self-service tools for feasibility queries
How to request research data or recruiting tools

3. Outline Sources of data at MUSC and HSSC How to request data
Feasibility
Chart review/data extract
recruitment
Examples of research uses of data

6. Feasibility Tools & Consultation
Self-service tools for de-identified patient counts
Honest Broker services for identified data & de-identified queries
Need help navigating the self-service tools? SCTR provides free Self-Service Research Data & Feasibility consultations
Epic and MUSC CDW report builds for research
Queries related to regional and national data networks

7. Epic/CDW data use examples
Patient Counts for Feasibility
Chart Review/Data extract for analysis
Recruitment
Data Preparatory to Research

8. Epic/CDW data use examples
Patient Counts for Feasibility
Chart Review/Data extract for analysis
Recruitment
Data Preparatory to Research

9. Self-Service Research Data & Feasibility Consultation Service
Epic
RDW
Slicer Dicer
Research Query Tool
Aggregate Data
Encounters since May 2012
Aggregate Data
Encounters since 1993
HSSC
StatewideData
i2b2

10. Self-Service Research Data and Feasibility

11. SlicerDicer
This tool allows de-identified query access to all patients available in Epic (Ambulatory 5/2012, Emergency 11/2012, Inpatient 7/2014)

12. SlicerDicer Access Complete training in MyQuest (search SlicerDicer)
Epic SlicerDicer for Research 2017 (interactive training online)
Once you complete the training in MyQuest, Paul Powers to enable your access
Additional available training in MyQuest:
Epic Research Creating a Population in SlicerDicer (tipsheet)
Epic Research Opening SlicerDicer (tipsheet)
Epic Research Requestihng PHI fro the Honest Broker in SlicerDicer (tipsheet)

13. Clinical Data Warehouse (CDW)
The MUSC CDW is a single, secure, integrated database extracted from the MUSC Clinical Data Repository, which includes (since 1993):
Patient demographics
Visit information
ICD-coded diagnoses and procedures
Medications
Laboratory test results
Etc.
Other fields are continually being added
Epic results since July 1, 2014
Self service access via the Research Query Tool

14. Clinical Data Warehouse
MUSC faculty and faculty-sponsored staff may access the CDW.
Faculty can sponsor full-time MUSC staff members by completing the sponsorship form and returning it
De-identified aggregate data
Restricted query interface
Data use assurance (DUA) to comply with HIPAA guidelines
Some aggregate, de-identified queries that are more complex/require multiple variables may need to be performed by an honest broker and requested through the Research Data Request process.

15. Clinical Data Warehouse
View a basic tutorial of the CDW self-query tool at

17. Example: Patient count for feasibility study

18. Example: Patients in medication class - feasibility

19. Health Sciences South Carolina (HSSC) Clinical Data Warehouse (CDW)
Health Sciences Health Improvement (HSHI), LLC, a South Carolina limited liability company, which is a wholly-owned subsidiary of Health Sciences South Carolina (HSSC), and Participants have been working to establish a statewide Clinical Data Warehouse (CDW) system as part of its mission to improve the health of all South Carolinians. The creation of the CDW and the data management platform support the goal of significant growth in clinical trials and medical research by facilitating collaboration across HSSC member organizations.

20. Health Sciences South Carolina (HSSC) Clinical Data Warehouse (CDW)
Those who have eIRB access have access to HSSC.   

21. MUSC i2b2 Project

22. How to gain access to i2b2
User management policy follows the same policy as the Research Query Tool
Who can access MUSC i2b2?
MUSC faculty and sponsored staff members have access
All non-faculty users must be sponsored by a MUSC faculty member;
completed Sponsorship
Access is granted within 1-2 business days.

23. MUSC i2b2 query tool

24. Example query

25. PCORI MUSC query tool

26. TriNetX: Data-Driven Clinical Trial Design & Recruitment
Real world data network of providers and pharma
August 2016 Go live at MUSC
2 years of Epic encounter data currently populated in TriNetX

27. MUSC Self-Service Feasibility Tools
Which self-service tool do I choose?
MUSC Self-Service Feasibility Tools
MUSC i2b2
TriNetX (consult service)
Epic SlicerDicer
CDW Research Query tool
User friendly interface X
Requires MUSC Faculty sponsorship
Training Required
Provide aggregate counts
Query by demographics
Query by medication orders
Query by labs
Query by Diagnosis
Use Sequential Criteria
Data available only after 7/2014
Query on Cancer registry data
Query based on encounter location
Create a query to share with an honest broker for recruitment patient list
Export a de-identified limited data set

28. Which self-service tool do I choose?
Do you need to receive more than aggregate counts of patients?
Do you need information counts for MUSC patients only
HSSC i2b2
(Includes MUSC, Greenville Health System, Palmetto Health, Spartanburg Regional Healthcare System)
Do you need data prior to 2014
Do you need cancer registry data or to filter by procedures?
SlicerDicer
MUSC i2b2
Research Query Tool
Will you need to receive identifiable data?
Will you need data prior to 2014
MUSC I2B2
Research Data Request
Will you need data only on your own clinical patients?
Will you need data prior to 2014?
Will you need cancer registry data or need to filter by procedures?
Yes No No
Yes No
Yes No
Yes No
Yes
Yes No No
Yes
Create a key for requires training, No
Yes

29. How do I ask for data for research BEYOND self service
Obtain IRB approval
Request through SCTR SPARC
Approval by Data Request Committee (usually in 24 hours)
Fulfilled by Epic or BMIC honest brokers

30. IRB Approved CDW Data Services
IRB approved process for Self-Service via i2b2 and Honest Broker for identified data access.
Details at:
CDW
IRB approval
Researchers
Results
Honest Broker
Data Use Agreement
aggregate data only
De-identified aggregate data
DRC
Self-Service Access
Brokered Access
MUSC and planned for HSSC.

31. Epic/CDW data use examples
Patient Counts for Feasibility
Chart Review
Recruitment
Data Preparatory to Research

32. Research Data Request

33. Tips for completing Research Data Request Form
Be as specific as possible with selection criteria
Include ICD9/ICD10 codes, CPT codes, etc.
Make sure the data points you are requesting, have been listed and approved in your IRB application/amendment
Including “Chart review” vs “Data Request” in your application
Exempt protocols can receive only clinical data OR identifiers but not both
Your Pre-Data Request consult will allow you to work with a data analyst to identify the most feasible and appropriate query for the purposes of obtaining the data you desire

34. Data Preparatory to Research Requests
Can be requested without IRB approval HIPAA Privacy rule preparatory to Research Provision
45 CFR (i)(1)(ii) 
The following attestation much be agreed upon and adhered to with regards to the received data
Because you selected "Preparatory to Research requiring identifiers", you must agree that:
(A) Use or disclosure is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research;
(B) No protected health information is to be removed from the covered entity by the researcher in the course of the review; and
(C) The protected health information requested is the MINIMUM level necessary for assessment of the feasibility of this research project

35. Epic/CDW data use examples
Patient Counts for Feasibility
Chart Review
Recruitment
Data Preparatory to Research

36. Research Data Request

37. Recruiting tools
Reports in EDW created by honest broker, run as needed
Epic Reporting Workbench
Best Practice Alerts
Pop ups for providers
InBasket messages for coordinators
Soft Alerts

38. Honest broker report Patients seen by Rheumatologists with lupus

39. Epic Reporting Workbench

40. Summary A great deal of data are out there
Aggregate data simpler to query (CDW, i2b2, SlicerDicer)
Patient level data available with IRB approval and Data Request Committee approval
All roads lead from SCTR SPARC
Quality improvement study data requests go to the Analytics Group

41.
sctr.musc.edu