Council of Research Associate Deans January 20, 2011

Agenda Project scope Essential functionality Timeline Opportunities for research community input Way to keep research community informed and involved

What SIRC Is (Project Scope) 3 In Scope Functional areas: Institutional Review Board (IRB) Administrative and Compliance Functions Institutional Animal Care & Use Committee (IACUC) Administrative and Compliance Functions Institutional Biosafety Committee (IBC) Human Subjects Research Compliance (HSRC) Controlled Substances (CS) Incoming Unfunded Research Agreements (UFRA) Compliance Related Training Verification Currently Out of Scope Submission of PRFs and Grant Proposals. Conflict of Interest Reporting Outgoing Unfunded Research Agreement HIPAA Training Management

What SIRC Will Do A flexible, robust web-based tool will ease administrative burden, create greater transparency and speed review throughout the life cycle of research projects. PIs and study staff will have the ability to submit, edit, clone and track submissions online. Transparency of review and approval status will provide a useful tool to gain and remain in compliance.

Key Features for Faculty and Research Community 5 Web-based Interfaces  Researcher “dashboard”  Online forms (new, amendments or change requests, continuing review, etc.)  Electronic submission, communications, and management processes Online “Smart Forms”  Leverage central authentication (x.500 login) to use existing Enterprise data (HR Contact, Training, Funding) when it exists rather than requiring user to enter.  Question-based logic enables relevant question areas and disables (grays out) non-relevant questions.  Can be started and edited by non-PI team members.  Can be started, saved as drafts, to be completed later.  Protocol submissions can be cloned and modified to reduce data entry.  Accepts multiple file formats for electronic attachments which supports a paperless process  Create and maintain consent forms (with version control) online Process Transparency  Researcher dashboard displays status of each submission in real time  Groups communications, action history, and relevant notes with protocol  Access to all versions of a submitted protocol

What we hope to achieve 6 Reduction in time needed to complete/revise application Reduction in common stipulations Reduction in approval lapses Improved review times Easier revisions Version control More complete and timely communication

Timeline 7

Opportunities for Researcher Input 8 WhatWhat it isWhen Listening Sessions Functionality overview, opportunities for involvement, feedback 12/17 9:00-10:00 12/20 11:30-12:30 12/21 9:00-10:00 Conference Room Pilot Review application prototype Researchers - 02/11/2011 Committee Members 02/10 Forms Review Review application design and content Spring/Summer 2011 Rollout Planning Identify plan to introduce SIRC across all user groups Winter 2012 User Acceptance Testing Hands on testing of application using realistic examples Spring 2012

Best Ways To Keep Research Community Informed? 9 Website Opt in list (Project updates, invitations to participate in future sessions) Research News Online Updates at Governance Groups, Review Committees, etc. Other?

10

Next Steps Conference Room Pilot (February ) Opportunity to provide feedback on design and functionality directly to the project team. 11

12 Questions? Comments? Feedback?