1. Clinical Research Informatics
Informatics Tools and Services Supporting the Clinical Research Life Cycle
Clinical Research Informatics
Bobby Moulden - OnCore Clinical Trial Management System
Tim Aro - Clinical Research Informatics

2. Wright CCTR – Clinical Research Informatics
Tools and Services
Wright CCTR – Clinical Research Informatics
Brief overview of informatics resources that are currently available via the Wright CCTR
Leveraging those informatics resources during the clinical research life cycle
How to request assistance on any of the available informatics resources
go.vcu.edu/bicrequest

3. Wright CCTR – Clinical Research Informatics
Tools and Services
Wright CCTR – Clinical Research Informatics
Electronic Data Capture (REDCap or OnCore)
Cohort Discovery (TriNetX / i2b2)
Data extraction – EHR (Cerner) and/or Billing System (IDX)
Research Collaboration Environment (Research Portal)
Grant Submission – Informatics Needs and Budgets
Honest Broker Services
Research Subject Recruitment - StudyFinder
Clinical Trial Management System (OnCore)
go.vcu.edu/bicrequest

4. Clinical Research Life Cycle
Grant Submission
Protocol Submission
Set-up
Study
Manage
Study
Analyze
Data
Does VCU Health have a patient population that supports this area of research?
i2b2 - Web Client for cohort discovery
TriNetX - Platform based on a global federated network – Multiple HCOs, Pharma, CROs
go.vcu.edu/bicrequest

5. Clinical Research Life Cycle
Grant Submission
Protocol Submission
Set-up
Study
Manage
Study
Analyze
Data
I have complex inclusion/exclusion criteria with crazy temporal dependencies – how could I gain insight into how these impact my cohort?
TriNetX - Platform based on a global federated network – Multiple HCOs, Pharma, CROs
go.vcu.edu/bicrequest

6. Clinical Research Life Cycle
Grant Submission
Protocol Submission
Set-up
Study
Manage
Study
Analyze
Data
What informatics resources are available and/or needed, and how do I obtain an informatics oriented budget estimate to include in my submission?
Electronic Data Capture - Setup and Support Fees (REDCap or Custom)
Data Extracts from Clinical Systems
Help Set-Up Collaboration Environment (Research Portal)
go.vcu.edu/bicrequest

7. Clinical Research Life Cycle
Grant Submission
Protocol Submission
Set-up
Study
Manage
Study
Analyze
Data
How do I let the IRB know I will capture, store, and manage sensitive research data in a manner consistent with HIPAA regulations?
Data extracted from our EHR by Wright CCTR CRI
Data stored in an “approved for research” HIPAA compliant environment - REDCap
Consult Wright CCTR CRI for assistance - access controls, workflows, technical controls - safeguards.
go.vcu.edu/bicrequest

8. Clinical Research Life Cycle
Grant Submission
Protocol Submission
Set-up
Study
Manage
Study
Analyze
Data
How do I meet my EDC needs?
go.vcu.edu/bicrequest

9. Clinical Research Life Cycle
Grant Submission
Protocol Submission
Set-up
Study
Manage
Study
Analyze
Data
I need clinical/study data from our EHR! My cohort was defined by my TriNetX query. Now what?
Re-identification - Wright CCTR CRI can match “fake” or synthetic IDs used by TriNetX with true identifiers and query the EHR - and provision those data.
go.vcu.edu/bicrequest

10. Clinical Research Life Cycle
Grant Submission
Protocol Submission
Set-up
Study
Manage
Study
Analyze
Data
How do I maintain data integrity in REDCap?
Perform periodic data quality checks
Lock records so they cannot be modified
Monitor the Log (audit trail)
go.vcu.edu/bicrequest

11. Clinical Research Life Cycle
Grant Submission
Protocol Submission
Set-up
Study
Manage
Study
Analyze
Data
Is there a secure collaboration environment to facilitate research team communication?
go.vcu.edu/bicrequest

12. Clinical Research Life Cycle
Grant Submission
Protocol Submission
Set-up
Study
Manage
Study
Analyze
Data
My data are ready for analysis – what is a secure way to get my data to my biostatistician?
Export scrubbed data – IDs removed
Give statistician access – export de-ID’d only
go.vcu.edu/bicrequest

13. Favor to ask - Associate REDCap projects with publications (PubMed)
go.vcu.edu/bicrequest

14. Tim Aro timaro@vcu.edu 804-628-4795
Tim Aro
go.vcu.edu/bicrequest

15. Demonstration of TriNetX Founders Room 12:15 to 12:45
VCU’s new Cohort Discovery Platform
Patrick Shi, IT Specialist, Wright Center for Clinical & Translational Research
Andrew Cohen, Clinical Operations Manager, TriNetX
Becca Fink, Product Manager, TriNetX
These TriNetX Experts will be available for Q&A throughout the day

16. OnCore and StudyFinder Bobby Moulden rbmoulden@vcu.edu
Study Management
OnCore and StudyFinder
Bobby Moulden
OnCore
go.vcu.edu/oncore
StudyFinder
go.vcu.edu/studyfinder

17. OnCore Online Collaborative Research Environment
Study Setup
Financials
Study Budgets
Negotiated Rates
SOC vs. Research
Payment Milestones
eCRFs
Forms Design
Assign Forms to Studies
Calendars
Procedures & Evaluations
Treatment & FU Schedules
Visit Tolerances
Footnotes
Clinical Research Management
Subjects
Screening
Registration
Consenting
Eligibility
Subject Status
SAEs
Deviations
Protocols
Basic Protocol Setup
Regulatory
Scientific Reviews
IRB Reviews
Protocol Activation
Visit Tracking & Data Capture
Automated Subject Calendars
Visit & Procedure Tracking
Additional Visits & Procedures
eCRF Completion
Query Resolution
Revenue Management
Automated Invoice Generation
Receivables Tracking
Unplanned Visits & Procedures
Exceptions
Study Data Management
Data Monitoring
Data Discrepancy Management
Data Export

18. OnCore - Feasibility Competing Studies
~900 active studies are tracked in OnCore Study data can be used to ensure there are no competing studies

19. OnCore - Feasibility Previous Enrollments
Use OnCore data to confirm ability to enroll specific populations
OnCore currently tracks ~5000 participants that are actively on studies
~1000 new enrollments per year.

20. OnCore - Feasibility Metrics
Example Request for Application (RFA):
List recent multi-center trials with the following:
Trial Name
Funding Source
Site PI
Time from award to IRB approval
Time from contract initiation to contract executed
Time from award to first patient enrolled
Enrollment rate
Number of patients enrolled
Ethnic, racial, and gender distribution
Patients lost to follow-up
Protocol Violations

21. Electronic Data Capture (eCRFS)
Two options for electronic Case Report Forms (eCRFS)
REDCap
Surveys
Participant Data Entry
Import external data
OnCore
Study Management
Financial Management
Data Query Module

22. OnCore – Study Management
Protocol
Principal Investigator
Study Site Contact
Study
Status
Open to Accrual Date
Sponsor
Accrual Goal
Total Accrual
CACZ885M2301
Abbate, Antonio
Cei, Laura
CLOSED TO ACCRUAL
7/8/11
Novartis 30 21
CLCZ696BUS01
Wohlford, George, F
OPEN TO ACCRUAL
8/8/16 20 17
DHART2
Carbone, Salvatore
8/1/14
NHLBI 60 31
EFC11570
Sears, Melissa, L
4/15/13
Sanofi-Aventis 15 7

23. OnCore/Cerner Integration

24. OnCore/Cerner Integration

25. go.vcu.edu/studyfinder

26. go.vcu.edu/studyfinder

27. go.vcu.edu/studyfinder

28. go.vcu.edu/studyfinder
Questions?
Tim Aro
go.vcu.edu/bicrequest
Bobby Moulden
go.vcu.edu/oncore
go.vcu.edu/studyfinder
cctr.vcu.edu