1. Research Management throughout
the Clinical Trial Lifecycle
UCSF Informatics Day
June 10, 2014
Lindsey Watt Alami, CCRP
Clinical Trials Specialist
Translational Informatics

2. Research
Landscape
OnCore
Overview
Managing
Study
Startup
Ongoing
Management
Tools
Questions

3. *Precision medicine
*Multi-institution collaborations
*Limited federal funding
Research Landscape

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. 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. 5 adoptions in 2013/2014 including UCLA CTSA/Enterprise

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. 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. OnCore
Clinical Trials
Research
Management
Billing
Compliance
Electronic
Data Capture
BioSpecimen
Management
Patient
Registries
Integration

10. *Coverage analysis and budget development
*Regulatory approvals
*APeX setup
*Form development
Communication between groups is critical!

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. 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. *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. *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. 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. *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. *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. 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. Investigators
• Track subject accruals
• Obtain program data for grant submissions
Administrators
• Track research finances
• Manage staff effort for resource planning

20. Registry for Clinical
Population
Specimen
Bank
Clinical
Trial
Clinical
Trial
Clinical
Trial
Clinical
Trial

21. To learn more about implementing OnCore
in your program, contact oncore@ucsf.edu