WHAT IS OUR RESEARCH PORTFOLIO?

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Elmer Green
6 years ago
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1 Clinical Research Management System Online Collaborative Research Environment (OnCore) Forte Research Systems Christian Stephens Office of Research Informatics Project Manager Mike Neuenfeldt Forte Project Manager Erica Reece Forte Product Specialist Carrie Nemke Forte VP Business Development Why an Enterprise CTMS? WHAT IS OUR RESEARCH PORTFOLIO? 1

Goals of OnCore Enterprise CTMS Enterprise Reporting Research Portfolio Patient Safety Insight into operations Research Operations Management Regulatory Compliance Improve communication &

2 Goals of OnCore Enterprise CTMS Enterprise Reporting Research Portfolio Patient Safety Insight into operations Research Operations Management Regulatory Compliance Improve communication & efficiencies Manage protocol lifecycle Financial Management Billing Compliance Accurate & consistent budgets Track sponsor invoicing Enterprise CTMS Benefits Research Staff Improved communication across team and sites Automation support (subject calendars & re-consenting sponsor invoicing) EMR & lab integration to eliminate duplicate data entry Leadership Visibility to clinical research portfolio at different levels within the enterprise Effectively manage staff workload Streamline budget negotiations Billing compliance Regulatory Standardized collecting and reporting of clinical research data Consistent tracking of safety data and staff credentials alerts and reminders Public Provides a searchable view of accurate and up-to-date open study information Patient safety 2

3 How Did We Get Here Duke Project Work Begins ONCORE RESEARCH ORGANIZATIONS 3

4 IMPLEMENTATION TEAMS Duke University Core Project Team Project Manager Christian Stephens Project Sponsors Mark Stacy Iain Sanderson Billy Newton Project Champions Lisa Varani Denise Snyder Cory Ennis Product Manager Terry Ainsworth OnCore Coordinators Lauren Horne Susan Natoli OnCore Trainers Virlesa Reed Kristy Astin Business Analyst Jeyalakshmi Ramanathan Finance Catee Mullen Cindy Maynard Tracy Kerby Calendars/Start Up Angie Padget DCI/Oncology Lori Pickens Ellen McCarthy Steinour Patrick Barrera MC Analyst Dalia Mack Ira Togo Earl Schwark Reporting/Data Analyst Rhodora Garcia Ron Griffith Matt Schultz Bill Shively PRMO Julie McCauley Ryan McGuire DUKE UNIVERSITY IMPLEMENTATION PLANS OnCore functionality: Protocol/subject management Calendars, coverage analysis Financials Interfaces: ADT (demographics), RPE (subject status), CRPC, (calendar) Custom SAP Interface eirb API Data migration: 14,000 study protocols to migrate All open studies in the IRB, all closed since January 1, 2013 Industry, Investigator Initiated, Grant, Federal Go-live Scope: Enterprise (SOM, SON, Campus Biomedical) Estimated protocols for initial go-live: 1500 Proposed timeline: Go-Live February

5 Duke Integrations DEMOGRAPHICS ONCORE API imedris Maestro Care (Epic) RPE CRPC(PROTOCOL BILLING GRID) CUSTOM INTEGRATION SAP Project Planning May 15 -Jun 30 Epic Interface Jun 5 -Sep 15 Application Setup Jun 12 -Jul 28 Project Working sessions Jun 19 -Jun 21 Community kickoff Jun 26 -Jun 28 Initial data migration Jul 10 -Sep 8 SAP interface Immersion Jul 25 -Jul 27 Training Train the Trainer Aug 7 -Aug 9 Session OnCore Champion Aug 21 -Sep 1 Training imedris (eirb) API System testing/data validation Financial Prep (Calendars/Budgets) End user Training Migration Go Live Go Live Jul 17 -Dec 1 Aug 14 -Dec 1 Sep 11 -Feb 2 Oct 8 -Feb 9 Dec 4 -Feb 9 Feb 8 -Feb 11 February May Jun Jul Aug Sep Oct Nov Dec 2018 Feb 2018 Today 5

ONCORE EVENT OUTCOMES June 19-21 June 26-28 July 25-27 June 12-Jul 28 Aug 21-Sep 1 Dec 17-Feb 18 Project Kickoff Refine scope and timeline Define communication plan Review project progress Community

Identify OnCore Champions Application Setup Configuration strategy decisions Application configuration Initial environment OnCore Champion Training Finalize high level workflows Finalize application

6 ONCORE EVENT OUTCOMES June June July June 12-Jul 28 Aug 21-Sep 1 Dec 17-Feb 18 Project Kickoff Refine scope and timeline Define communication plan Review project progress Community Kickoff Understanding of OnCore usefulness by Research Community Communicate scope and timeline Generate excitement Immersion Initial OnCore high level workflows Initial application configuration Identify OnCore Champions Application Setup Configuration strategy decisions Application configuration Initial environment OnCore Champion Training Finalize high level workflows Finalize application configuration Documentation of detailed policies and processes End User Training End Users demonstrate competence when using OnCoreand prepared for Golive Finalize preparations for Go-Live How can I be involved in this exciting process? Read the DOCR Clinical Research Update newsletter Go to the WIKI and see what s going on at the OnCore page (select WATCH) Use the training opportunities to learn the application Ensure the information on your research studies are accurate Volunteer for a work group in an area that you know a lot about 6

7 Proposed Work Groups needing your participation Budgeting Calendar Building Cancer Central Office Community Engagement Contracts (includes ORC) Credentialing Grants (includes ORA) Invoicing Participant Management Protocol Management Publish to the Web Reporting Research Pricing Scientific Review Task Lists Training User Roles Volunteer Registry Questions during the Demo? Please send any questions about OnCore or the project to 7

8 Forte Attendees Mike Neuenfeldt Project Manager Ann Kreeger Program Manager Erica Reece Product Specialist Carrie Nemke VP Business Development Denali Stahlke Business Development Manager John Starr CFO ONCORE RESEARCH ORGANIZATIONS 66% NCI-Designated Cancer Centers 32% NIH-CTSAs 8

9 ONSEMBLE A Collaborative Community Onsemble.net Conferences Groups Resources Collaborations Training Webinars Documentation SOP & Reports Library Onsemble Spring Conference Onsemble Fall Conference CTO Admins OnCore Coords Training Regulatory OnCore Developers Network Financials/CA ebooks Articles Webinars Q&A s Research Operations Metrics Enterprise Implementation Billing Compliance Biospecimen Management EVOLUTION OF SPECIALIZED SOFTWARE Standardization Enterprise-wide Standards Research Group Standards Study Specific Study Specific Research Group Study Specific Specialization Evolving with the research community and regulations to manage reporting compliance and operations across the entire enterprise 9

10 OnCore Demo ONCORE CLINICAL RESEARCH WORKFLOW Research Administration PROTOCOLS Protocol Attributes Committee Reviews Protocol Activations CALENDARS Procedures Schedules Visit Windows SUBJECT MANAGEMENT Pre-screening Subject Status SAEs and Deviations SUBJECT VISIT TRACKING Automated Subject Calendar Visit Management Reset Future Dates Printable View Financials SETUP FINANCIALS Billing Designation Create Budget Milestone Setup VISIT VARIATIONS Additional Visits Addl/Missed Procedures REVENUE MANAGEMENT Invoice Generation Receipt Tracking Alerts 10

OnCore Billing Compliance Workflow Demonstration

OnCore Billing Compliance Workflow Demonstration Srini Kalluri, Founder, President & Chief Customer Officer Carrie Nemke, Business Development Manager CTMS Support of Billing Compliance Best Practices Research Compliance Conference Austin TX, June 2013