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 oncore@ucsf.edu