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Improving the Business of Research Administration With Click Kevin Wong Tony Haber

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1 Improving the Business of Research Administration With Click Kevin Wong Tony Haber

2 Agenda  8:30 – 9:00Continental Breakfast  9: :00Company Introduction & Product Overview  10:00 – 11:00Case Study 1 - Proposal and Budget Development and Modification  11:00 – 12:00Case Study 2 - Electronic Routing, Approvals, and Submission  12:00 – 12:45Lunch  12:45 – 1:45Case Study 3 - Award & Sub-award Creation  1:45 - 2:30Case Study 4 – Conflict of Interest (COI)  2:30 – 2:45Break  2:45 – 3:30Case Study 5 - IRB full board submission  3:30 - 4:30Q&A © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.

3 Focused Approach to the Marketplace Focused services to meet client demands Healthcare Helping hospitals improve quality, increase revenues, reduce expenses and enhance patient/employee satisfaction. Higher Education and Life Sciences Helping universities and research institutes, academic medical centers, and pharmaceutical companies and device manufacturers develop and implement strategic, financial, operational, and regulatory solutions. Legal Helping corporate legal departments and law firms control costs and improve efficiency related to discovery and operational challenges. Financial Services Helping corporations address financial and operational matters. Focused services to meet client demands: Leading the way forward in Healthcare, Education, Life Sciences, Legal, and Financial Consulting © 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 3

4 Operations We deliver solutions that span all functional areas including human resources, finance and accounting, procurement, facilities, information technology, research administration, clinical research, student administration, enrollment management, auxiliary enterprises, among others. Strategy We partner to develop strategies and actionable plans to improve performance at the institutional, school, or department levels. Scalable Solutions Technology Our solutions help clients better utilize technology to support the core administrative processes across the enterprise, as well as understand and manage the costs associated with technology. Huron Education YOUR MISSION | OUR SOLUTIONS © 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 4

5 Our Values INTEGRITY | We do the right thing regardless of the consequences. PURSUIT OF EXCELLENCE | We continually strive to exceed the expectations of our people and our clients. ACCOUNTABILITY | We take responsibility for individual and collective actions. COLLABORATION | We work together to achieve collective and individual goals. PASSION | Our energy and enthusiasm are contagious. We are inspired to make a lasting impact. 5 © 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.

6 Huron Education Software and Services 6 © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Software System Implementation Services Project Planning Portal Architecture Functional Design Configuration System Testing Documentation & Training Deployment Services Sustaining Services Click™ Portal Software Products Research Administration – Grants -- Contracts -- Awards -- MTA Research Oversight -- IRB -- COI -- IACUC & AOPS -- Safety Committees Clinical Trials Management Improved Research Administration Business Processes Consulting Services Core Functions: Research, Finance, Procurement, HR, IT, Facilities Research Solutions: Strategy, Organization, Business Process, Financial Management, Cost Reimbursement, Risk Management, Change Management Regulatory and Finance Experts

7 Why Technology + Services Matter  The correct application of technology and subject matter expertise saves time and money Improved processes before automation Process advice and benchmarking over the life of the installation maintains efficiency  Single vendor ensures even results Consulting, technology, implementation and support services all under one roof  Software alone is not the solution Automation of the right processes = high efficiency 7 © 2011 Huron Consulting Group, Inc.

8 Click ® Portal 8 © 2011 Huron Consulting Group, Inc. Click Portal Starter Sites Clinical TrialsComplianceResearch Administration Participant Tracking and Billing Clinical Trials Recruitment IRB IACUC Safety Committees Grants & Contracts Animal Operations and Ordering Auditing Conflict of Interest Existing Systems Animal Database Accounting Human Resources Electronic Medical Record Web Services SF424 eSubmission Grants.gov Researcher Profile Direct SQL Data Warehouse Interface Tables

9 How Huron’s Solutions Help 9 © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.  Simplifying processes for administrators & researchers  Maintaining compliance as regulations change  Improving researcher satisfaction with reduced administrative burden  Providing organizations a platform for continuous improvement

10 Who’s Using Click Portal Solutions? American Heart Association Arizona State University Case Western Reserve University Cedars-Sinai Health System Chesapeake Research Review, Inc. Children’s Hospital Boston Childrens Hospital of Los Angeles The Children’s Hospital of Philadelphia The Mercy Children’s Hospital Children’s National Medical Center Cincinnati Children’s Hospital Medical Center Cleveland Clinic Dartmouth College Duke University East Carolina University Emory University Fox Chase Cancer Center Georgetown University Georgia Health Sciences University Hackensack University Medical Center Harvard University Health Sciences South Carolina Hospital for Special Surgery The Johns Hopkins University Kaiser Hawaii/GA Kaiser Permanente Northwest Lawrence Berkeley National Laboratory Louisiana State University Health Sciences Center Shreveport Lehigh Valley Health Network Mayo Clinic MD Anderson Cancer Center Medical College of Wisconsin The Methodist Hospital Research Institute The MetroHealth System NASA-Johnson Space Center New York University Langone Medical Center National Bureau of Economics Northwestern University Ochsner Clinic Foundation The Ohio State University Ontario Institute of Cancer Research Oregon Health & Science University The Pennsylvania State University RAND Corporation The Research Institute at Nationwide Children’s Hospital Rush University Medical Center St. Jude Children’s Research Hospital Texas Health Research & Education Institute University of Alberta University of Arkansas for Medical Sciences University of British Columbia University of Calgary University of California Los Angeles University of California San Diego University of Chicago University of Cincinnati University Corporation for Atmospheric Research University of Florida University of Kansas / KUMC University of Maryland University of Massachusetts Medical School University of Medicine & Dentistry of New Jersey University of Miami University of Michigan University of Pittsburgh University of Rochester University of South Florida University of Southern California University of Texas at San Antonio University of Texas Southwestern Medical Center at Dallas University of Utah University of Washington University of Wisconsin VA Pittsburgh Healthcare System Virginia Commonwealth University Wake Forest University Weill Cornell Medical College 10 © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.

11 Grants and Contracts Customers  Arizona State University  Case Western Reserve University  Children’s Hospital Boston  The Children’s Hospital of Philadelphia  Cincinnati Children’s Hospital Medical Ctr  Children’s Mercy Hospital  Dartmouth College  Lawrence Berkeley National Laboratory  Mayo Clinic  Medical College of Wisconsin  Methodist Hospital Research Institute  New York University Langone Medical Center  Ochsner Clinic  The Research Institute at Nationwide Children’s Hospital  Rush University Medical Center  Seattle Children’s Hospital  St. Jude Children’s Research Hospital  University of British Columbia  The University of Chicago  Tufts Medical Center  University Corporation for Atmospheric Research  University of Arkansas Medical School  University of Massachusetts Medical School  University of Michigan  University of New Mexico  University of Southern California/Children’s Hospital Los Angeles  University of Texas Southwestern Medical Center at Dallas © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 11

12 2012 New Customers 12 1)Arizona State University* 2)Case Western Reserve* 3)Children's Hospital Colorado 4)NTBN Foundation 5)Harvard University 6)National Bureau of Economic Research (NBER) 7)Sanford Health 8)Tufts Medical Center 9)University of Georgia* 10)University of Kansas 11)University of Mexico* 12)West Penn Allegheny Health System © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. * New Grants customers

13 2012 Click® Portal Go-lives 13 1)CCF COI 2)Chicago COI 3)Chicago IRB 4)CHOP COI 5)CHOP CTMS 6)CMH IRB 7)Dartmouth Grants 8)NTBN Foundation COI 9)Georgetown IRB 10)Harvard IRB 11)HSS IRB 12)KU COI 13)LBNL IACUC 14)LSU COI 15)LSU IRB 16)NBER COI 17)NYULMC Full Grants 18)NYULMC IBC 19)NYULMC Portal 20)OSU CTMS 21)Sanford COI 22)UCLA COI 23)UCSD MTA 24)UMASS IRB 25)UNM IRB 26)USC COI 27)VCU COI 28)West Penn COI 29)CHC CTMS 30)USC IACUC © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.

14 Research Administration Software Models 14 © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Click Portal Time to Deploy Flexibility To Match Your Needs Packaged Application Custom Development Slow Fast Low High Low High Consistent/Committed Support

15 Click Portal Overview 15 © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Portal Framework Click Portal Application + Tools for Configuring Click Portal Starter Site Core Low-Level Functionality Portal Functionality & Tools Solution, SmartForms, Workflows, Microsoft ® Microsoft Platform & Tools

16 Click Portal Overview 16 © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Portal Framework Click Portal Application + Tools for Configuring Click Portal Starter Site Portal Framework Click Portal Application + Tools for Configuring Click Portal Customer Configured Site Configuration Custom / Integrations Microsoft ®

17 Click SmartForms™ 17 © 2011 Huron Consulting Group, Inc.  Molded to your forms  Draw upon other institution forms  Dramatically reduces error input  Conditional branching between pages  Error checking; completion summaries  Configurable help text  Reviewer’s notes

18 Intelligent Routing Processes 18 © 2011 Huron Consulting Group, Inc.

19 Industry Leading Ability to Change 19 © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Type of ChangeExampleDev. effort (minimum) Text changeRephrase questionMinutes Add simple data fieldFree text boxMinutes Add componentDocument uploadMinutes Alter a form set and its existing branches New regulatory info. required Hours Expand routing review pathNew reviewer requiredHours Adopt new functional enhancement Incorporate reviewer’s notes Days Include to a new committee review process Add a review board with meetings and minutes 1 – 2 Weeks

20 Click Grants & Contracts © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 20  Configurable routing –Institutional look and feel, help text –Routing for chair, scientific, SPO, IO –FOA feeds from Grants.gov – notifications and reminders  Collaborative online budgeting –Departmental and SPO contributors –Auto-calculates fringe & indirect rates –Copy / reuse any budget  Ensuring accurate, complete grants.gov eSubmissions –Easy electronic forms population using browsers –Maps from budgets to SF424  Document Review / Negotiation  Award Management –Award Budgeting; Setup Information –Awards, Umbrella Awards, Sub-Awards, etc. –Follow-on submissions: Continuations, Revisions, Renewals, Re-submissions, etc. –Deliverables Tracking & Reminders  Integrated reporting SF 424

21 Pre-Award Grant Management 21 © 2010 Click Commerce, Inc Funding Proposal Description Related Protocols Reviews Award Sponsor Budget Sponsor & Institutional Profiles Workflow SF424 Contracts Sponsor Budget Personnel

22 Award Management © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 22 Award (e.g., NIH R01) Award (e.g., NIH R01) Terms & Conditions Periods of Performance Deliverables Funding Allocation 1 ($350K, Period 1) Funding Allocation 1 ($350K, Period 1) Funding Allocation 2 ($250K, Period 2) Funding Allocation 2 ($250K, Period 2) Funding Proposal 1 Budget Sponsor Profile Workflow Budget Funding Proposal 2 Budget Supplemental ($200K, Period 1) Supplemental ($200K, Period 1)

23 Grants Phasing (example)  Phase I (GrantsXpress)- o eSubmission Implementation o Routing Sheet Design and Workflow o Routing Sheet Mapping to SF424 o SF424 electronic submission to grants.gov  Phase II - o Other Proposal Types o Online Budgeting o Post Awards o Legacy Integration 23 © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Phase I GrantsXpress Phase 2

24 Why Huron’s Click Portal? © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 24  A Complete Solution  The most comprehensive suite of products and services for research administration  Configurable Software  Architected for rapid configuration to support continuous process improvement  Industry Expertise  Huron has worked with over 90% of the top research organizations in North America and the Click User Group is the most active in the industry  Financial Stability  Huron is a $600M profitable organization

25 Questions © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 25

26 COI Terminology 26 Disclosure: Any outside financial interest or activity Enter the data once Reuse the data every time Can be updated or retired as needed © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Certification: A reason or “trigger” for re-stating or re-reviewing a person’s disclosures Disclosure data is automatically filled in Answer questions specific to the reason for re- certifying Gets Routed & Reviewed

27 Certifications Annual Update Merck New Research Grant Speak at a conference February March April May JuneJuly August © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. System sends to User asking them to complete certification statement System re-uses Disclosure data for each certification. Updates are carried forward

28 IRB Office Workflow 28 Incoming Request New Information Pre-Review Non-Committee Review Prep Non-Committee Review Conduct Committee Review Prep Committee Review Conduct Post-Review Submission Decision Approve Require mods Disapprove Protocol state Submitted Approved Suspended Terminated Lapsed Pre-Review Acknowledged

29 © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 29 Click Portal Architecture IRB Grants and Contracts SF424 eSubmission Conflict of Interest Clinical Trials Billing IACUC Animal Operations Biosafety (IBC) Chemical Safety Radiation Safety Effort Reporting Material Transfers Research Catalog Web Services Business Process Modeling Query / Reporting Services Powerful Extranet Security Delegated Administration Collaboration Components Document Management Page Layouts/Templates Notification User-Extensible Data Model Personalization Browser-based Configuration Tools Developer Tools C# COM Object Model Automatic Data Persistence Transaction Management Integrated Security Web Services Unified Query System Caching/Session Management Schema Management Windows 2008 Server IIS SQL Server 2008 Indexing Service Component Services.NET Framework Solutions Application Layer Extranet Framework Microsoft Platform

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