1. UCSF IT Governance Committee on Research Technology Clinical Trials Management System (OnCore CTMS) Sorena Nadaf, M.S., M.MI April 13 th, 2012

2. History and Background April 8 th 2011 Presentation to OE Steering Committee –Project Purpose : Deploy a clinical management system leveraging existing technology and resources – a multi Phased Approach –Project Scope Phase I: Licensing, Implementation, Infrastructure Readiness, Support Team, Assessment and Audit for programs identified in early round adoption of OnCore –Out of Scope Phase I: Integration with EPIC, iRIS, Migration of legacy trials 2

3. 3 Stages I, II, III Initial Go Live May… June July AugSeptOct Nov Dec2012... Stage I : May 31 st 1- Contract Negotiations – O# 2-Implementation Plan 3-New Staff Positions 4-Training Outline 5- Primary Support Infrastructure in Place 6-SOP outline reviews and discussions Stage II: July 29th Assessments of early adopters Multidisciplinary Infrastructure Expansion Complete All New Protocols at UCSF to open to accrual (CRM, BSM, URM) SOP’s underway Special Interest Groups identified Initial GO LIVE Stage III : By July 2012 Continued Assessments: Expanded List EPIC and iRIS Projects Outlined Early Migration Needs Identified SOD Integration Outlined Communication Plan Complete

4. 4 Stages IV & V We are here Jan… June July AugSept… Jan 2013 June July2014... Stage IV : By July 1 st 2012 1- SOD Integration Complete 2-Open House Events Complete 3-Continued Training Expansion 4-Internal Advisory Board in Place 5-Expanded Support Infrastructure in Place 6-iRIS Integration Mapping Stage V: By Jan 2013 Full Campus Adoption Underway iRIS Integration Complete RPE Harmonization and Testing Financial Billing and Billing Compliance, Medicaid Coverage Analysis EPIC Lab Values data Integration testing TBD Certification Program for CRC’s and Data Managers Expanded Quality Assurance and Quality Control Metrics Review and assessment of home grown systems and data mapping + integration – 100’s!

5. Early Phase Adopters Rasopothies Clinic (Peds) Urology Radiology Pulmonary Neurology Cardiology CTSI Diabetes Center AIDS Specimen Bank Non Malignant Heme 5

6. OnCore Statistics Total Trained Users : 653 Concurrent Active Users : 485 Total Protocols: 3483 Total Active Protocols: 1386 Total Subjects: 15644 Total Active Subjects: 7912 Total Number Subject Forms: 36817 Total Protocol Documents : 20860 Total Number Customized Reports: 137 6

7. Enterprise Rollout Decisions and Strategies Expansion Preparation –OnCore Layers –Reference Codes –Notifications –Protocol Annotations –Forms –Sign Offs Creation of Domain Specific Libraries –Ongoing and aligned with Phases of project 7

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9. 9 TaskEstimated HoursStart DateEnd DateResponsible Initial Project Meeting Introduction to OnCore/ Discuss OnCore Functionality 2 CRISS Team Introduction to OnCore for faculty leadership 2 CRISS Team Identify and prioritize program objectivesOnCore Adopter Determine scope of OnCore utilizationOnCore Adopter Implementation Plan and Schedule Identify implementation leadership and primary and secondary contactsOnCore Adopter Establish communication plan with program leadershipCRISS Team Establish regular meeting schedule with the Adopter primary and secondary contactsCRISS Team Identify staff that staff that will require OnCore accessOnCore Adopter Determine which data capture systems will be replaced by OnCoreOnCore Adopter Determine protocol(s) to pilot in OnCoreOnCore Adopter Create implementation scheduleCRISS Team Training Plan Draft a prospective training plan CRISS Team Plan training sessions for all staff by access role CRISS Team General Configuration of the OnCore Environment Adopter provides review of workflow/SOPs for current processesOnCore Adopter Provide department and unit alignmentOnCore Adopter Determine whether new library is requiredCRISS/OnCore Adopter If new library is needed, complete configuration spreadsheetOnCore Adopter Configuration for Pilot Protocol(s) Create data collection configuration in OnCore training environment 8 per protocol CRISS Team Review data collection configuration/Provides written feedback 2 OnCore Adopter Confirm standard domain configurationCRISS Team Resolve outstanding issues with data collection configurationCRISS Team Final approval of data collection configurationOnCore Adopter Training Sessions (as needed per staff access role) Protocol Management Training Session 2 CRISS Team Subject Management Training Session 5 CRISS Team Financial Training 2 CRISS Team Biospecimen Management Training 2 CRISS Team Clinical Team Training 1 CRISS Team Investigator Training 1 CRISS Team Statistician Training 1 CRISS Team Monitor Training 1 CRISS Team OnCore production accounts activated for all trained staff 1 CRISS Team Post Go-Live Activities Enter protocols into production environmentOnCore Adopter Enter individual subject accrual info for active protocolsOnCore Adopter Enter biospecimen data for active correlative protocolsOnCore Adopter Query and validate data entered into OnCoreOnCore Adopter Create research budgets in financial consoleOnCore Adopter Monitor usage and operationsCRISS Team Provide feedback on operationsOnCore Adopter Provide adhoc training and guidance on pilot protocolsCRISS Team Resolve identified issuesCRISS Team Verify project completionCRISS/OnCore Adopter

10. Demonstrated Benefits of OnCore Rollout Implementation : Feedback “I like to be able to function independently. If I need information about my study or the patients in my study, I do not want to have to rely on anybody, and OnCore make that possible” Feedback List of Advantages: –Improved reporting of safety data Calendar based system allows for real time monitoring, grading and reporting of AE’s, impacting compliancy –Improved organization of regulatory material Reduction of paper needed in study binders; improves organization by keeping electronic copies of CVs, licenses, IND Safety Reports, Protocols, etc…. In ONE place easily accessible by study personnel from different locations 10

11. More Feedback Feedback List of Advantages: –Improved Time to Activation Metrics PI and Research Administration export this data for showcasing metrics in reports to leadership –Standardization of training and workload for CRC’s Reports of significant time savings in training newly hired CRC’s due to Standardized process tied to system and support personnel –Easier Management of CRC’s and Data Entry Personnel –Easier access to study data 11

12. APeX – OnCore Collaboration TI/CRISS participation in bi-weekly Clinical Trial Work Group Steering Committee Meetings OnCore data extraction –Study data as source for configuration and data validation for trials in APeX –Initial configuration for June 2012 go-live and ongoing verification b/n systems as new studies are activated –Billable research procedure information for active trials. ‘APeX Research Documentation’ checklist is updated in OnCore to indicate when billable procedures and patient participation has concluded. –Research patient status information for initial go-live 12

13. CRISS Domain Experts Providing Clinical Trial Administrative and Scientific Support Addressing Critical needs for effective data and data quality management Converting laborious, personnel-intensive tasks into automatable, consistent workflows Develops and provides the governance for high quality, reproducible, and automated methods for clinical data acquisition Maintain and keep up to date UCSF OnCore Knowledge Center and users Wiki Data Quality Control and Auditing 13

14. CRISS Services Calendar and CRF Development –Assist with the implementation of the protocol in OnCore by assessing factors that influence the electronic configuration of data capture such as the schedule of assessments, participation sites, and the research and clinical staff CRF Design –Developing clinical case report forms that employ standards based data elements and principles of scientific parsimony in collaboration with the PI and Biostatistician Instructional Guidance –Training the data entry personnel to enter data based on the data capture plan 14

15. CRISS Services continued Data Monitoring –Providing instruction in the use of the CTMS for real- time review of clinical data and creating reports that facilitate monitoring Data Retrieval and Extraction –Assist study personnel to retrieve data as necessary 15

16. Events and Priorities Onsemble 2012 a great success CTMS Open House –Mt Zion –Parnassus –Mission Bay OnCore Advisory Panel Communication Plans 16

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18. Committee on Research Technology Subgroup Clinical Research Infrastructure (CRI) Sorena Nadaf, M.S., M.MI April 13 th, 2012

19. CRI Charge – (proposal) To Develop a UCSF Wide Clinical Research Infrastructure (CRI) Architecture ‘Charter’ with the goal to not only standardize systems, but to harmonize and enable the structured collection, exchange, and integration of distributed, multi-dimensional, heterogeneous clinical and biomedical data. 19

20. CRI Forum – (proposal) Further examination of regulatory, administrative, and structural barriers to the effective conduct of clinical research and its impact on infrastructure. Develop a vision and roadmap for a stable, continuously funded clinical research infrastructure. Develop strategies and collaborative activities to facilitate more robust engagement in the clinical research enterprise. 20

21. CRI Charter– (proposal continued) As the starting point for the Forum’s work, it is our hope that this subgroup will serve as a resource for all organizations and individuals seeking a greater understanding of how the clinical research infrastructure roadmap under construction at UCSF works and how it can improve. 21

22. CRI Charter– (proposal continued) Ultimately, as our healthcare system architecture expansions moves forward, our work will serve as a source of information and standardization to those involved in clinical research as sponsors, investigators, clinicians, patients, and especially policy makers. 22

23. CRI Charter– (proposal continued) Ultimately, as our healthcare system architecture expansions moves forward, our work will serve as a source of information and standardization to those involved in clinical research as sponsors, investigators, clinicians, patients, and especially policy makers. 23

24. CRI Possible Membership Sorena Nadaf (Chair) – (Co-Chair TBN) Susanne Hildebrand-Zanki Margaret Tempero Michael Prados Elizabeth Boyd Clay Johnston Bill Balke John Heldens Eric Mah David Avrin Matt Cooperberg Ida Sim Michael Blum Russ Cucina Yao Sun Stuart Gansky SOP Representative SON Representative 24

25. Focus & Projects – (Proposal) iMedris iRIS Stabilization Biospecimen Management Clinical Research Processes for APeX OnCore Suite (CRM / BSM / URM) REDCap Real Time Participant Recruitment Services(s) Next Generation Sequencing Clinical Research Data Marts Clinical Research Data Standardization CRI - Carrots and Sticks 25

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