UCSF Informatics Day 2014 - Lindsey Watt Alami, "Study Management throughout the Clinical Trial...
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Transcript of UCSF Informatics Day 2014 - Lindsey Watt Alami, "Study Management throughout the Clinical Trial...
Research Management throughout the Clinical Trial
Lifecycle
OnCore
UCSF Informatics Day
June 10, 2014
Lindsey Watt Alami, CCRP
Clinical Trials SpecialistTranslational Informatics
Agenda
Research Landscape
OnCore Overview
Managing Study
Startup
Ongoing Manageme
nt Tools
Questions
*Precision medicine
*Multi-institution collaborations
*Limited federal funding
Research Landscape
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
OnCore Overview
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)
2012 OnCore Research Organizations5 adoptions in 2013/2014 including UCLA
CTSA/Enterprise
Translational Informatics
• 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
Who Benefits?
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
OnCore
Clinical Trials
ResearchManagemen
tBilling
Compliance
Electronic Data
Capture
BioSpecimen
Management
PatientRegistries
Integration
Study Activation
*Coverage analysis and budget development
*Regulatory approvals
*APeX setup
*Form development
Communication between groups is critical!
Study Activation in OnCoreShare 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
Sample Start-up Metrics Report
Event Time in Days for Protocol
Average Time in Days
Across TeamDays 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 ContractExecuted
98 87
Days from Protocol Received from the Sponsor to Open to Accrual 102 100
Protocol Management
*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
Calendar Functionality
*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
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 DrugDrugAdminV1 X X X X
Adverse Events AE V1 X X X
Investigator-Initiated Studies
*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
Multicenter Collaborations
*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
Industry-Sponsored TrialsPost-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
Research Program Management
Investigators
• Track subject accruals
• Obtain program data for grant submissions
Administrators
• Track research finances
• Manage staff effort for resource planning
OnCore as a comprehensive research
tool
Registry for Clinical
Population
Specimen Bank
Clinical Trial
Clinical Trial
Clinical Trial
Clinical Trial
Questions
To learn more about implementing OnCore in your program, contact [email protected]