1. Claire McKinley, PMP, CCRP
OnCore Overview
Claire McKinley, PMP, CCRP
January 2018

2. Can you tell me?
How many Clinical Trials have you and your colleagues opened in the last year?
How many subjects did your team enroll last month?
How many subjects do you have that are currently On Study?
What are the demographics of your subject population?

3. OnLine Collaborative Research Environment (OnCore®)
Comprehensive clinical research management system
Developed though collaboration with research organizations across the country for 14 years
Provides functionality for supporting best practices
Manages all protocols and subjects in one place
Used in the Cancer Center Office of Clinical Research (OCR) since 2011
Requires less customization than other systems

4. Overall System Goals and Strategic Plan
Develop enhanced clinical research infrastructures and support via IT-driven solutions to the entire UVA clinical research community
Replace current decentralized methods of recording clinical research activity
Ultimately reduce administrative redundancy

5. CTMS Benefits Improved communication across teams
Better access to information
Standardized processes across the institution
Integrated subject schedule management
Faster/simplified billing for sponsors

6. OnCore Features Protocol and Subject Lifecycle Management
Calendars and Schedule of Events
Financial Management- Coverage Analysis, Budget Negotiations and Sponsor Invoicing
Effort Tracking
Adverse Event collection and aggregate reporting
Reporting- Accrual, Custom Reports, Protocol Violations, Demographics
Task Management
Customizable notifications
Document repository
Electronic Data Capture for Investigator Initiated trials

7. Standard Notifications
The Steering Committee determined a list of default automatic notifications for all studies in OnCore.
These can be customized per protocol on the Notifications Tab on each protocol.
Standard Notifications
Notification Type
Who Receives
Protocol Status [CLOSED TO ACCRUAL] Notice
Study Team
Protocol Status [OFF HOLD] Notice
Protocol Status [ON HOLD] Notice
Protocol Status [OPEN TO ACCRUAL] Notice
Protocol Status [SUSPENDED] Notice
Protocol Status [TERMINATED] Notice
IND FDA Approval Notice
CTO
IND Submission Notice

8. Reporting Accrual Reports Enrollment Reports Effort Tracking
Financial Reports
Subject Demographics

9. How will all of our systems work together?
IRB Online and OnCore are integrated
IRB sends protocol and consent approval dates, study status, version dates, review types and IRB actions.
EPIC and OnCore are integrated
EPIC sends all demographic information to OnCore (so you just can search by MRN)
OnCore will send EPIC all study staff members listed & subjects (and their status) registered to the study in OnCore will be tagged in EPIC.
CR Connect and OnCore will be integrated

10. Epic RPE (“Retrieve Protocol for Execution”)
Creates Protocol Record in Epic
Previously a manual process done by the CTO
Will update changes to protocol status and staff as they occur after the connection is made
Associates Subjects with Protocol in Epic once associated in OnCore

11. RPE- Protocol Information Sent
Protocol Number
Title
Short Title
NCT Number
IRB Number
Protocol Staff PI
Protocol Arm Code & Description
Protocol Type

12. Epic Research Protocol Page

13. RPE- Subject Information Sent
Subject Status
Associated Protocol #
Active Start Date
Active End Date
Protocol Arm
Subject ID # (‘Sequence Number’ in OnCore)

14. OnCore to Epic Subject Mapping

15. Epic Research Subject Page
Once the link is made between OnCore and Epic, subject status updates will automatically sync. However, if necessary, study teams will still be able to manually edit their subject status in Epic.

17. Minimum Data Set
Only Full Board or PRC Approval Required Protocols will be entered
Basic Protocol & Subject Information will be required
IND/IDE information required (if UVA held)
Data Entry documentation found on the UVA OnCore Resources Page

18. New Policies and SOPs UVA Clinical Trial Management System Policy
Full Board OR
Requires PRC review
Required data set in the Data Entry Guide
Access Requirements
SOPs
Access Requests
Required Training
Custom Report Requests
Data & Data Entry
Exceptions Requests
Inclusion in OnCore
Exclusion from OnCore
Exclusion from Epic Interface
OnCore Support

19. OnCore Support We have a formal request system for end user support
Tickets will be entered by the support team into SysAid and you will be able to track their status there
Phone:
SOPs/Policy/Data Entry Guides/Checklists

20. Timeline