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

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?

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

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

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

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 email notifications Document repository Electronic Data Capture for Investigator Initiated trials

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

Reporting Accrual Reports Enrollment Reports Effort Tracking Financial Reports Subject Demographics

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

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

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

Epic Research Protocol Page

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

OnCore to Epic Subject Mapping

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.

https://www.medicalcenter.virginia.edu/intranet/cto/oncore-help/

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

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

OnCore Support We have a formal request system for end user support Email: OnCoreSupport@hscmail.mcc.virginia.edu Tickets will be entered by the support team into SysAid and you will be able to track their status there Phone: 434-297-5757 SOPs/Policy/Data Entry Guides/Checklists https://www.medicalcenter.virginia.edu/intranet/cto/oncore-help

Timeline