1. OnCore: Clinical Trials Management Joshua Lee, MD Information Services

2. Overview 2 What is OnCore CTMS? What are the intended integrations? How does this meet enterprise goals? What is the unique nature of being dual institutional?

3. Clinical Trials Management System Sponsor Management Which grants are linked to a sponsor? Protocol Management What does the calendar dictate ? Subject Management In which trial is the participant enrolled? Reports and Financials/Invoices What is OnCore? 3

4. ONE (1) instance of the application between the USC entities (Keck + all schools) and CHLA Covers (initially) all human studies that require performed clinical service Others can be added later Includes Industry, Federal Cooperative Group, Federal individual and Investigator Initiated Trials USC/CHLA Scope 4

5. Manages staff, linked grants, and various review steps Key step is tracking of concurrent IRB review Once feasibility and scientific review (when indicated) are complete, then study can be “linked” to a series of enterprise systems: IRB, Grants, Fund accounts (iStar, K Coeus, K financials, Peoplesoft) Initiating a Trial 5

6. Manages Tracking of Review 6

7. Common study number between iStar and CTMS Design decision NOT complete Whether scientific review is completed in iStar or in OnCore (EPRMS workflow tool) Depending on that decision, it will make one of the two the “master” of the study number Application interface is purchased and will be programmed as part of phase 1 Integration 1 7

8. Proposed Data Flow for iStar 8

9. Calendaring is Performed 9

10. Budget Created From Visits + Fees 10

11. At USC: once a study is “launched” (IRB review initiated) KC is launched to allow for appropriate grant/contract mgmt CTMS only “keeps track” of the grant linked to the sponsor but does not replace KC/KFS integration where grant  fund account. KC/KFS are the “master” systems Live feed NOT recommended for Phase 1 Integration 2 11

12. Sponsor-Grant Linkage 12

13. At CHLA, the “master” of the fund account is Peoplesoft Makes excess complexity in the initial phase to attempt two live feeds The bulk of the invoice/payment management can occur within OnCore, and the totals applied back to the respective general ledgers Endorsed by operational project team Integration 2, cont’d 13

14. Proposed “Fund” Creation 14 Live means “OK” to analyze

15. Invoices Can be Generated 15

16. Sample Outbound Invoice 16

17. Payments can be posted against specific invoices, greater transparency 17

18. Participants are enrolled in trials Their eligibility is assessed Treatment and follow up periods are tracked Significant adverse events are monitored Progress along the study calendar is assessed for compliant, comprehensive and transparent billing Subject Management 18

19. Subject Tracking 19

20. Visit Specific Monitoring 20

21. The dual institution master patient index (MPI) (from the two instances of Cerner) FEEDS the CTMS with all potential participants (merges duplicates) The CTMS FEEDS the respective electronic health records with the compendium of all studies and the participant enrollment (along with status—eligible, on study, off study) Integration 3 (Matched Pair) 21

22. Recommended for phase 1 PowerTrials is the “vehicle” by which the study information is stored in the electronic health record Trial enrollment and participant’s status at that time is indicated in the banner Integration 3 22