1. Business Model and Administration Governance
Andy Arenson
Denise Snyder

2. Five years ago in Cincinnati, we learned...
Do-IT-Yourself
Build-It-For-You
FREE
Funded by CTSA or institution
Cost recovery
Nominal hosting fee, consulting hours
-Hourly rate or percent effort
-Budgeted service in grants/contracts
REDCap – “free”, as in puppy, not as in beer

3. Post REDCapCon survey about business models (n=23 responders)
Do-It-Yourself at no cost (14)
Build-It-For-You at cost(11)
Do-It-Yourself at cost (5)
Build-It-For-You at no cost (4)
Other models mentioned included:
If dept supported, no charge for those dept sponsored projects, but charges to other depts
Fees for special requests, complex work

4. Rates then… Nearly all charges per project versus per user
Four responders gave rates for charge/project (range $ )
Hourly rates (range $30-285) and percent effort for those not offering flat rates
Hourly rate dependencies:
Level of person performing work
Multi-site
Using DTS
Industry sponsor vs Investigator initiated

5. Mandate/Guidance No site reported mandating use of REDCap
12 sites reported strong guidance, 10 did not, 1 indicated that REDCap is approved by IRB, but not mandated or strongly encouraged
Areas of institutional support for REDCap
CTSA
IRB
Biostatistics IT
Cancer Center
Clinical Informatics
Data Management

6. Metrics…wouldn’t these be nice to have?
Hours of customer support
Hours of development/project work
Number of grants supported
% grants supported
Customer satisfaction
Help desk tickets
Dashboard/system stats (#projects, surveys, users, performance db size, storage used)

7. Governance
“Establishment of policies, and continuous monitoring of their proper implementation, by the members of the governing body of an organization. It includes the mechanisms required to balance the powers of the members (with the associated accountability), and their primary duty of enhancing the prosperity and viability of the organization.”1
NOTE: bold and underline by Andy Arenson
1http://
NOTE: Emphasis by presenter

8. Governance
Who are your sponsors and stakeholders? Who should make which decisions? Who should have which powers? Can range from very informal to very formal

9. Governance @ Penn State University (adapted from content by Terri Shkuda)
Sponsor - Clinical Translational Science Institute (CTSI)
Stakeholders - IRB, Informatics, IT, User Representation, Quality, Marketing, Cyber Security
Strategic decisions - By Governance Team of Sponsor and Stakeholders.
Acceptable use; Access roles; Training requirements; Feature adoption; SOPs
Day-to-day decisions - By REDCap Administrator
Move to production; Problem resolution; Design consultation; Upgrades; Access Control; User Support
Decisions made:
Service Level Agreement – Upgrades; Backup/Recovery; Test strategy
Training – Training required (in-person, tutorial, peer-level)
Access -- Provided by a centralized IT Accounts Management group to ensure separation of duties.
Marketing/Communications - Website (login, training schedule, tips&tricks, citing templates); Notifications, Banners on Home Page, Trifold brochure

10. Resource Allocation @ PSU (2016)
REDCap Administrator
.6 FTE
REDCap Developer
.4 FTE
REDCap System Administrator
.1 FTE
Accounts Management (minimal FTE)
Help Desk (minimal FTE)
Currently, no charge for all services.
NOTE: These current staffing levels are inadequate to fully support REDCap’s current active user base of 800 users.

11. Governance @ Indiana University
Sponsor – Indiana Clinical and Translational Science Institute
Stakeholders – Biostatistics, IT, User Representation (recently begun), Compliance (not formally determined)
Strategic decisions - By CTSI, Biostatistics, and IT managements
Acceptable use; Access roles; Training requirements; Feature adoption; SOPs
Day-to-day decisions - By REDCap team (User support, technical support)
Move to production; Problem resolution; Design consultation; Upgrades; Access Control; User Support
Decisions made:
Service Level Agreement – Upgrades; Backup/Recovery; Test strategy (In progress)
API access – Requires extensive SOP unless not using ePHI, only importing data, or in some cases for individual analysis on protected workstations.

12. Resource Allocation @ IU (2017)
User Support, Training, and Outreach
~1.2 FTE (recently brought in 2nd person to help with account creation)
Technical support
0.7 FTE
Oversight
~0.2 FTE
System Administration, Database Administration (no direct charge)
Hourly consulting charges for project design; No other charges
NOTE: Inadequate to fully support current active userbase of 2,126 customers.

13. Governance @ Duke University
Sponsor – Duke Clinical and Translational Science Institute and Duke University School of Medicine
Stakeholders – Office of Clinical Research, Biostatistics, IT, Research Informatics (ORI), User Representation (not formally determined), Security
Strategic decisions - By Office of Clinical Research, IT/ORI management, and Security
Acceptable use; Access roles; Training requirements; Feature adoption; SOPs
Day-to-day decisions - By REDCap team (User support, technical support)
Move to production; Problem resolution; Design consultation; Upgrades; Access Control; User Support
Decisions made:
Service Level Agreement – Upgrades; Backup/Recovery; Test strategy
Training – Training strongly suggested for non-REDCap team builders
Access - Provided by a centralized IT Accounts Management group, and project level access controlled REDCap Administrators
API access – Requires written requests, granted on per project basis

14. Resource Allocation @ Duke
REDCap Admin/Developers (1 FTE)
REDCap System Admin (.2 FTE)
Project Builds, Training, Support (7 FTE)
Oversight (1 FTE)
System Administration, Database Administration (no direct charge)
Effort Allocation for project builds on contract; No other charges
NOTE: Current effort model supports nearly 5500 users