UCSF IT Governance
Committee on Research Technology
Clinical Trials Management System
(OnCore CTMS)
Sorena Nadaf, M.S., M.MI
April 13th, 2012
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
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Stages I, II, III
Initial Go Live
May…
June
July
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
Aug
Sept
Oct
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
Nov
Dec
2012...
Stage III : By July 2012
•Continued Assessments:
Expanded List
•EPIC and iRIS Projects
Outlined
•Early Migration Needs
Identified
•SOD Integration Outlined
•Communication Plan
Complete
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Stages IV & V
We are here
Jan…
June
July
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
Aug
Sept… Jan 2013 June
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
July
2014...
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!
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Early Phase Adopters
• Rasopothies Clinic (Peds)
• Urology
• Radiology
• Pulmonary
• Neurology
• Cardiology
• CTSI
• Diabetes Center
• AIDS Specimen Bank
• Non Malignant Heme
5
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
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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
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Task
Estimated Hours
Start Date
End Date
Responsible
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 objectives
OnCore Adopter
Determine scope of OnCore utilization
OnCore Adopter
Implementation Plan and Schedule
Identify implementation leadership and primary and secondary contacts
OnCore Adopter
Establish communication plan with program leadership
CRISS Team
Establish regular meeting schedule with the Adopter primary and secondary contacts
CRISS Team
Identify staff that staff that will require OnCore access
OnCore Adopter
Determine which data capture systems will be replaced by OnCore
OnCore Adopter
Determine protocol(s) to pilot in OnCore
OnCore Adopter
Create implementation schedule
CRISS 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 processes
OnCore Adopter
Provide department and unit alignment
OnCore Adopter
Determine whether new library is required
CRISS/OnCore Adopter
If new library is needed, complete configuration spreadsheet
OnCore Adopter
Configuration for Pilot Protocol(s)
Create data collection configuration in OnCore training environment
Review data collection configuration/Provides written feedback
8 per protocol
2
CRISS Team
OnCore Adopter
Confirm standard domain configuration
CRISS Team
Resolve outstanding issues with data collection configuration
CRISS Team
Final approval of data collection configuration
OnCore 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 environment
OnCore Adopter
Enter individual subject accrual info for active protocols
OnCore Adopter
Enter biospecimen data for active correlative protocols
OnCore Adopter
Query and validate data entered into OnCore
OnCore Adopter
Create research budgets in financial console
OnCore Adopter
Monitor usage and operations
CRISS Team
Provide feedback on operations
OnCore Adopter
Provide adhoc training and guidance on pilot protocols
CRISS Team
Resolve identified issues
CRISS Team
Verify project completion
CRISS/OnCore Adopter
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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
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
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
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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
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
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CRISS Services continued
• Data Monitoring
– Providing instruction in the use of the CTMS for realtime review of clinical data and creating reports that
facilitate monitoring
• Data Retrieval and Extraction
– Assist study personnel to retrieve data as necessary
15
Events and Priorities
• Onsemble 2012 a great success
• CTMS Open House
– Mt Zion
– Parnassus
– Mission Bay
• OnCore Advisory Panel
• Communication Plans
16
17
Committee on Research Technology Subgroup
Clinical Research Infrastructure
(CRI)
Sorena Nadaf, M.S., M.MI
April 13th, 2012
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
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.
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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
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.
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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.
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CRI Possible Membership
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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
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Focus & Projects – (Proposal)
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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
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