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UCSF Informatics Day 2014 - Lindsey Watt Alami, "Study Management throughout the Clinical Trial Lifecycle using OnCore"

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UCSF Informatics Day 2014 - Lindsey Watt Alami, "Study Management throughout the Clinical Trial Lifecycle using OnCore"

  1. 1. Research Management throughout the Clinical Trial Lifecycle UCSF Informatics Day June 10, 2014 Lindsey Watt Alami, CCRP Clinical Trials Specialist Translational Informatics
  2. 2. Research Landscape OnCore Overview Managing Study Startup Ongoing Management Tools Questions
  3. 3. *Precision medicine *Multi-institution collaborations *Limited federal funding Research Landscape
  4. 4. Research Landscape *EHR *Billing compliance *Centralization of institutional resources *Turnover of research staff To support ongoing research in a program, both innovative research and effective operations management is critical for sustainable success
  5. 5. OnCore: Online Collaborative Research Environment Comprehensive clinical research data capture and management system in use at the University of California San Francisco and affiliate sites *Clinical Research Management (CRM) *Unified Registry Management (URM) *BioSpecimen Management (BSM)
  6. 6. 5 adoptions in 2013/2014 including UCLA CTSA/Enterprise
  7. 7. • Clinical & Biomedical Research Subject Matter Experts • Certified OnCore Application Managers • Application Architects and Database Engineers • Project Managers OnCore Support: *Application maintenance *Training and support for staff & investigators *Calendar & form creation *Standardization of data elements and processes
  8. 8. Study Team • Primarily benefits investigators and research staff • Tracking subject visits, protocol activities, and clinical data collection Post-award Analyst • Communication tool with the study team • Create invoices and reconcile payments Administrators • Search and reporting tools for protocol, subject, and financial data at the program and institution level
  9. 9. OnCore Clinical Trials Research Management Billing Compliance Electronic Data Capture BioSpecimen Management Patient Registries Integration
  10. 10. *Coverage analysis and budget development *Regulatory approvals *APeX setup *Form development Communication between groups is critical!
  11. 11. Share protocol details and materials Record the plan for billing compliance Track regulatory approvals (e.g. CHR, FDA) Track the study start-up timelines and effort to identify barriers and manage resources
  12. 12. Sample Start-up Metrics Report Event Time in Days for Protocol Average Time in Days Across Team Days from Site Selection to Scientific Review Approval 3 24 Days from Contract and Budget Received to Draft Budget Sent to the Sponosr 45 44 Days from Contract and Budget Received to Budget Approved by the Sponsor 21 30 Days from IRB Submission to IRB Approval 70 65 Days from Contract and Budget Received to Contract Executed 98 87 Days from Protocol Received from the Sponsor to Open to Accrual 102 100
  13. 13. *Ability to track scientific review, CHR, FDA, and other safety approvals and expirations *Consent form versioning and reconsent flag The Vision • iRIS integration to limit manual entry • OnCore protocol and billing information to serve as the record for the APeX study build
  14. 14. *Record of study procedures and timepoints *Calendar provides the framework for billing designations, study budget, and data collection *Set the framework to track events per subject
  15. 15. 1 2 3 4 5 Screen Baseline Week 2 Week 4 Week 6 Planned Date 01/28/2014 02/11/2014 02/24/2014 03/10/2014 03/24/2014 Visit Status Occurred Occurred Occurred Occurred Planned Visit Date 01/28/2014 02/11/2014 02/28/2014 03/10/2014 Informed Consent X Demographics/Medical History DemFormV1 X Vital Signs VS Form V2 X X X X X Physical Measurements [a] X X X X X Peripheral Blood Mononuclear Cell X X Clinical Laboratory Tests [d] LabsV11 X X X X X Physical Exam [b] ExamV1 X X X X Stool Sample [e] X X X Diary and questionnaire review X X X X X Lab handling and/or shipping of specimen(s) X Endoscopy X Dispense Study Drug DrugAdminV 1 X X X X Adverse Events AE V1 X X X
  16. 16. *Electronic Data Capture (EDC) functionality *Centralized library of Case Report Forms (CRFs) *Standardized data elements (e.g. ICD-9/10, CTCAE) *Query and validation functionality *Reporting tools The Vision *Subject demographic data currently feeds over from APeX *Next stage of APeX integration will allow lab results to populate in the forms
  17. 17. *Investigators & staff from participating sites can receive (limited) access to update protocol and subject data *Track regulatory approvals for all sites *Communicate safety events through automated safety notices
  18. 18. Post-award Management • Subject enrollment and visit verification trigger sponsor milestones for invoicing • Eliminates emails and spreadsheet to communicate between the study team and post-award staff
  19. 19. Investigators • Track subject accruals • Obtain program data for grant submissions Administrators • Track research finances • Manage staff effort for resource planning
  20. 20. Registry for Clinical Population Specimen Bank Clinical Trial Clinical Trial Clinical Trial Clinical Trial
  21. 21. To learn more about implementing OnCore in your program, contact oncore@ucsf.edu

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