Mayo Clinic Research Participant Tracking (PTrax) C3PR Data/Services Adoption

1. Mayo ClinicResearch Participant Tracking(PTrax) C3PR Data/Services Adoption May 9, 2011 Mayo Clinic Confidential

2. Mayo Clinic From Mayo Clinic 2010 Facts & Highlights Mayo Clinic Rochester and Mayo ClinicHealth System Mayo Clinic in Arizona Mayo Clinic in Florida 56,100 Total Employees 3,700 Physicians and Researchers

3. Research Education Clinical Practice

4. Research Activity 2010 From Mayo Clinic 2010 Facts & Highlights External funding $393M New protocols reviewed by IRB 2,384 Active human research studies 8,030 Research publications 5,072 Research Personnel 3,233 Physicians and scientists 388 Students 538 Allied health 2,307

5. Research Management System Comprehensive Research Management System Streamline processes, manage effectivelyand efficiently Create digital platform to transform business transactions Increase Mayo and Mayo’s research visibility Attract extramural funding

6. Research Management SystemPREVIOUS CustomerDescriptors Operations supporting research • Reactive • Cumbersome • Lengthy • Expensive • Uncoordinated • Bureaucracy • Insufficientresources Projects Customer Service?

7. Research Management SystemTRANSFORMED CustomerDescriptors Operations supporting research • Cost effective • Useful • Integrated • Competitive • Best-in-class • Efficient • Agile • Valued Projects Customer Service

8. Near-Term CRMS Technology Aims Creation of Digital Platform Electronic informed consent process Web based electronic signatures iPad digital signature capture Streamlined, consistent and integrated research billing Practice (patient care) integrations – EMRs, scheduling systems and integrated care processes

9. Longer-Term CRMS Technology AimsDigital Platform Protocol authoring and streamlined workflow Registration and regulatory management Adverse events reporting and management Interventional trial notification in EMRs Integrated drug/device collision management Integrated patient recruitment mining and screening

10. What is Research Participant Tracking (PTrax)? • An institutional research system that is designed to facilitate the management of participant / study status, accrual management, streamline informed consent processing and history for study participants. What Participants? • All Mayo site study participants who have been consented using the Mayo IRB informed consent process for either written or verbal consents Mayo Clinic Confidential

11. Business Value – PTrax • Streamlined Accrual Management • Patient Safety • Compliance/Regulatory • Streamlined consent and re-consent processing • Centralized and secure participant information • Enable research enterprise wide business intelligence and ad-hoc reporting of subject/study information • Enable efficient bio-specimen management processes • Improve billing and accounting accuracy • Policy compliance monitoring - enforcing participant registration rules • Measure screen failure rates (signed consent vs. Accrued) Mayo Clinic Confidential

12. PTrax - Key Features • Track and Manage informed consent documents and processes • Retrieve and print informed consent documents • Track consenting history of all study participants • Identify the need for re-consents from IRBe system info • Capture consent bio-specimen handling questions and participant responses • Track and Manage the current and historical status of all study participants • Track the major participant status/milestones through the life of the study, including dates and reason codes for statuses • Enrollment and Accrual target management • Track IRB approved actual enrollment (consented) and accruals (registered) and compare each against target • Provides safeguards to avoid exceeding targets Mayo Clinic Confidential

13. PTrax - Key Features • Integration with IRBe (Click Commerce) • Multiple Informed Consent integration points • Provides the mechanism to populate the IRB continuing review form with accrual/withdrawal/screen failure data directly from PTrax • Integration with Medidata Rave • Current participant status updates are pushed real-time from Rave to PTrax • Demographics pushed real time from PTrax to Rave • Participant Safety • Alerts study teams when a participant is participating in multiple studies concurrently • Reporting • Study specific on-demand reporting • Cross study aggregate reporting Mayo Clinic Confidential

14. Study / Participant Lifecycle Study/Participant Timeline Active Intervention Phase Deliver Informed Consent Informed Consent Signed Pre-Consent Screening Post-Consent Screening Registration & Randomized Observation Long Term Follow-up Complete Contacted Accrued Completed Consent Prepared Enrolled Decline Consent (reason codes – Optional and study defined) Active Intervention Screen Failure (reason codes – Primary are global Secondary are study defined) Long Term Follow-up Observation Withdrawn (reason codes – Globally defined) Participant Status Transitions Mayo Clinic Confidential

15. PTrax Application Architecture with C3PR Services Adoption Study Management Application UI Participant Management Application UI Informed Consent Management Application UI EDC Applications IRB, Financial, EMR Applications Adoption Mayo Specific Business Logic, Client Convenience/Wrapper Interfaces Integration Mayo Specific Study Mgnt Service Study Management / Subject Management / Subject Registry Services (C3PR) Mayo Specific Protocol/IC Services caBIG CSM Mayo Specific Authorization Services Services Mayo Specific Study Data Model Ext. Data Model (C3PR) (Oracle) IRBe (SQL Server) Mayo CTMS (DB2) Data caBIG/C3PR Components Custom Built Subject Registry Components Existing Systems Mayo Clinic Confidential

16. C3PR Services Adoption Benefits • BRIDG aligned data model • Ability to integrate with existing systems • Allows for ease of adoption of C3PR Registration • Subject Registry will integrate with Subject Registration • Easily incorporate Mayo specific business logic • Reduction in overall project time and cost Mayo Clinic Confidential

17. Registration / Registry Integration • C3PR can provide consistent interfaces to manage mapping of status from the registration system to the registry (one-way) • Actual mapping logic could be provided by institution C3PR Registration System Registry Subject Identity Subject Demography Consent Records Epoch/Subject Workflow High-level Status Mapping ‘Plug-in’ S1 – 01/01/2010 12:00pm E1 E2 E3 E2 E4 S2 – 01/02/2010 11:00pm S3 – 02/10/2010 03:00pm S4 – 02/10/2010 03:00pm S5 – 02/15/2010 10:00am Mayo Clinic Confidential

18. System Interaction Diagram PTrax Mayo Patient Registration Demographics Medidata Rave Status Demographics CRF Informed Consent CRF Common Custom Function Security CRF CRF CSM IRB Mayo Clinic Confidential

19. Moving Forward • Extend PTrax Functionality • Electronic informed consents • Integration with EMRs/Scheduling • Accrual / Portfolio dash boarding • Continue to leverage BRIDG • Maintain interoperability • Including CDE compliance • Evaluate C3PR for Enterprise-Wide Subject Registration • Evaluation of additional products / services Mayo Clinic Confidential

20. Questions? Mayo Clinic Confidential