Business Model and Administration Governance Andy Arenson Denise Snyder

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

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

Rates then… Nearly all charges per project versus per user Four responders gave rates for charge/project (range $95-4000) 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

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

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)

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://www.businessdictionary.com/definition/governance.html. NOTE: Emphasis by presenter

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

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

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.

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.

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.

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

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