Improving the Business of
Research Administration
With Click
Kevin Wong
kwong@huronconsultinggroup.com
Tony Haber
thaber@huronconsultinggroup.com
Agenda
8:30 – 9:00
Continental Breakfast
9:00 - 10:00
Company Introduction & Product Overview
10:00 – 11:00
Case Study 1 - Proposal and Budget Development and Modification
11:00 – 12:00
Case Study 2 - Electronic Routing, Approvals, and Submission
12:00 – 12:45
Lunch
12:45 – 1:45
Case Study 3 - Award & Sub-award Creation
1:45 - 2:30
Case Study 4 – Conflict of Interest (COI)
2:30 – 2:45
Break
2:45 – 3:30
Case Study 5 - IRB full board submission
3:30 - 4:30
Q&A
© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
Focused Approach to the Marketplace
Focused services to meet client demands
Focused services to meet client demands: Leading the way forward in Healthcare, Education,
Life Sciences, Legal, and Financial Consulting
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.
© 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
3
Huron Education
YOUR MISSION | OUR SOLUTIONS
Scalable Solutions
Strategy
We partner to develop strategies and actionable plans to improve
performance at the institutional, school, or department levels.
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.
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.
© 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
4
Huron Education Software and Services
Consulting Services
Software System
Implementation Services
Click™ Portal Software
Products
Core Functions:
Research, Finance,
Procurement, HR, IT, Facilities
Project Planning
• Research Administration
– Grants
-- Contracts
-- Awards
-- MTA
Portal Architecture
Research Solutions:
Functional Design
Strategy, Organization,
Business Process, Financial
Management, Cost
Reimbursement, Risk
Management, Change
Management
Regulatory and Finance Experts
Documentation & Training
• Research Oversight
-- IRB
-- COI
-- IACUC & AOPS
-- Safety Committees
Deployment Services
• Clinical Trials Management
Configuration
System Testing
Sustaining Services
Improved Research Administration Business Processes
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
6
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
© 2011 Huron Consulting Group, Inc.
7
Click® Portal
Existing Systems
Click Portal Starter Sites
Clinical Trials
Compliance
Research
Administration
Participant Tracking
and Billing
IRB
Grants & Contracts
Clinical Trials
Recruitment
IACUC
Grants.gov
Safety
Committees
Animal Operations
and Ordering
Auditing
Researcher Profile
Conflict of Interest
© 2011 Huron Consulting Group, Inc.
SF424 eSubmission
Web
Services
Direct
SQL
Human
Resources
Accounting
Animal
Database
Interface
Tables
Electronic
Medical Record
Data
Warehouse
8
How Huron’s Solutions Help
Simplifying processes for
administrators & researchers
Maintaining compliance as
regulations change
Improving researcher
satisfaction with reduced
administrative burden
Providing organizations a
platform for continuous
improvement
© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
9
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
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
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
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2012 New Customers
1)
2)
3)
4)
5)
6)
Arizona State University*
Case Western Reserve*
Children's Hospital Colorado
NTBN Foundation
Harvard University
National Bureau of Economic
Research (NBER)
7)
8)
9)
10)
11)
12)
Sanford Health
Tufts Medical Center
University of Georgia*
University of Kansas
University of Mexico*
West Penn Allegheny Health
System
* New Grants customers
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
12
2012 Click® Portal Go-lives
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
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
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
13
Research Administration Software Models
High
Click
Portal
Custom
Development
Flexibility
To Match
Your Needs
Packaged
Application
Low
Low
Slow
© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
Consistent/Committed Support
Time to Deploy
High
Fast
14
Click Portal Overview
Starter Site
Click Portal Application +
Tools for Configuring Click
Portal
Portal Framework
Microsoft®
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
Solution, SmartForms, Workflows,
Portal Functionality & Tools
Core Low-Level Functionality
Microsoft Platform & Tools
15
Click Portal Overview
Configuration
Customer Configured Site
Click Portal Application +
Tools for Configuring Click
Portal
Click Portal Application +
Tools for Configuring Click
Portal
Portal Framework
Portal Framework
Microsoft®
Microsoft®
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
Custom / Integrations
Starter Site
16
Click SmartForms™
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
© 2011 Huron Consulting Group, Inc.
17
Intelligent Routing Processes
NEW
1) Pre Submission
PI
Submit Study
DEPT
Issue Departmental Approval
DEPT
Changes Required By Department
2) Department Review
3) Changes Required
By Center
4) Veterinarian
Review
5) Changes Required
By Veterinarian
PI
Submit Changes
VET
Submit Veterinarian Review
VET
Changes Required By Veterinarian
PI
Submit Changes
6) IACUC Staff
Review
© 2011 Huron Consulting Group, Inc.
18
Industry Leading Ability to Change
Type of Change
Example
Dev. effort (minimum)
Text change
Rephrase question
Minutes
Add simple data field
Free text box
Minutes
Add component
Document upload
Minutes
Alter a form set and its
existing branches
New regulatory info.
required
Hours
Expand routing review path
New reviewer required
Hours
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
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
19
Click Grants & Contracts
Configurable routing
–
–
–
–
Institutional look and feel, help text
Routing for chair, scientific, SPO, IO
FOA feeds from Grants.gov
Email notifications and reminders
SF 424
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
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
20
Pre-Award Grant Management
Funding Proposal
Award
Sponsor
Description
Budget
SF424
Related Protocols
Reviews
Sponsor
Contracts
Budget
Personnel
Budget
Award
Workflow
Sponsor & Institutional Profiles
© 2010 Click Commerce, Inc
21
Award Management
Award
(e.g., NIH R01)
Terms &
Conditions
Periods of
Performance
Deliverables
Funding
Allocation 1
($350K, Period 1)
Funding
Allocation 2
($250K, Period 2)
Supplemental
($200K, Period 1)
Funding Proposal
1
Budget
Budget
Funding Proposal
2
Budget
Budget
Workflow
Sponsor Profile
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
22
Grants Phasing (example)
Phase I (GrantsXpress)o
o
o
o
eSubmission Implementation
Routing Sheet Design and Workflow
Routing Sheet Mapping to SF424
SF424 electronic submission to grants.gov
Phase II o
o
o
o
Other Proposal Types
Online Budgeting
Post Awards
Legacy Integration
© 2011 Huron Consulting Group. All Rights Reserved.
Proprietary & Confidential.
Phase I
GrantsXpress
Phase
2
2
3
Why Huron’s Click Portal?
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
© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
24
Questions
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
25
COI Terminology
Disclosure: Any outside financial interest or activity
• Enter the data once
• Reuse the data every time
• Can be updated or retired as needed
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 recertifying
• Gets Routed & Reviewed
© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
26
Certifications
February
Annual
March
April
Update
Merck
System sends email to User
asking them to complete
certification statement
© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
May
New
Research
Grant
June
July
August
Speak at a
conference
System re-uses Disclosure
data for each certification.
Updates are carried forward
IRB Office Workflow
Non-Committee
Review Prep
Incoming
Request
Pre-Review
Post-Review
Committee
Review Prep
New Information
Non-Committee
Review Conduct
Pre-Review
Acknowledged
Committee
Review Conduct
Submission Decision
•Approve
•Require mods
•Disapprove
Protocol state
•Submitted
•Approved
•Suspended
•Terminated
•Lapsed
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Click Portal Architecture
IRB
Grants and Contracts
SF424 eSubmission
Conflict of Interest
Clinical Trials Billing
IACUC
Animal Operations
Biosafety (IBC)
Chemical Safety
Radiation Safety
Application Layer
Business Process Modeling
Query / Reporting Services
Powerful Extranet Security
Delegated Administration
Collaboration Components
Document Management
Page Layouts/Templates
Email Notification
User-Extensible Data Model
Personalization
Extranet Framework
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
Solutions
Microsoft Platform
© 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
Effort Reporting
Material Transfers
Research Catalog
Web Services
Browser-based
Configuration Tools
Developer
Tools
Component Services
.NET Framework
29
