1 / 26

UCSF IT Governance Committee on Research Technology Clinical Trials Management System (OnCore CTMS)

UCSF IT Governance Committee on Research Technology Clinical Trials Management System (OnCore CTMS). Sorena Nadaf, M.S., M.MI April 13 th , 2012. History and Background. April 8 th 2011 Presentation to OE Steering Committee

cassia
Download Presentation

UCSF IT Governance Committee on Research Technology Clinical Trials Management System (OnCore CTMS)

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. UCSF IT GovernanceCommittee on Research TechnologyClinical Trials Management System(OnCore CTMS) Sorena Nadaf, M.S., M.MI April 13th, 2012

  2. History and Background • April 8th 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

  3. Stages I, II, III Initial Go Live May…JuneJulyAugSeptOctNov Dec2012... Stage I : May 31st 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. Stages IV & V We are here Jan…JuneJulyAug Sept… Jan 2013June July2014... Stage IV : By July 1st 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

  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

  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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

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

  15. Committee on Research Technology SubgroupClinical Research Infrastructure (CRI) Sorena Nadaf, M.S., M.MI April 13th, 2012

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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

  22. 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

More Related