1. 2011 ACRIN Annual Meeting ACRIN ACCELERATED ACCRUAL DEMONSTRATION PROJECT Department of Radiology The University of Iowa Carol Mertens, Ph.D., CFLE, LMHC Principal Investigator W. Allen McGruder Departmental Research RA

2. 2011 ACRIN Annual Meeting ACKNOWLEDGEMENTS Sincere thanks & appreciation to: –Dr. Laurie Fajardo, MD Radiology Department Chair The University of Iowa –Lisa Lang, BLS, CRA Research Administration Department of Radiology, U of I

3. 2011 ACRIN Annual Meeting ACKNOWLEDGEMENTS Sincere thanks & appreciation to: –Nancy Fredericks, MBA Director, ACRIN Communications Project Leader, Accelerated Accrual –Cynthia Olson, MBA, MHS RESCUE Project Manager

4. 2011 ACRIN Annual Meeting ACCELERATED ACCRUAL AT UNIVERSITY OF IOWA Our proposal focuses on a team collaboration approach spearheaded by a Departmental Clinical Research Coordinator (DCRC) charged with the overall coordination of all ACRIN-based clinical imaging trials and initiatives within the department.

5. 2011 ACRIN Annual Meeting U of I Proposed Overall Strategy We proposed that modeling and employing a team approach would provide a more efficient and productive research environment that is conducive to replication and implementation across ACRIN sites. Elements of team approach: –Enhanced communication, –Shared knowledge and expertise, –Outreach to team members, and –Acknowledgement & Appreciation

6. 2011 ACRIN Annual Meeting DCRC Not committed to one single trial or PI Brings expertise to all ACRIN clinical trial teams: –Works to determine trial feasibility –Trial preparation and activation responsibilities –IRB application & regulatory items –ACRIN research protocols/organizational initiatives –Oversees open trials on a macro-basis –Radiology Research Support Group

7. 2011 ACRIN Annual Meeting DCRC Work in partnership with Department of Radiology Imaging Research Cores and University of Iowa Carver College of Medicine Research Support Cores to: –establish trial-specific research teams for each ACRIN trial conducted at University of Iowa and –coordinate regular ACRIN trial meetings, monitor trial accrual, data submission, and timelines.

8. 2011 ACRIN Annual Meeting DCRC Serve as University of Iowa liaison with ACRIN Key person in successful organization and start-up of ACRIN trials at the University of Iowa. Assist with remote monitoring and on-site audits by ACRIN

9. 2011 ACRIN Annual Meeting DCRC Serve as the Regulatory Specialist by coordinating regulatory requirements with ACRIN and/or other committees within the University (i.e. Safety, Pharmacy, etc.) Conduct periodic reviews of potential issues inherent in research trials –Regulatory –Compliance –IRB reviews

10. 2011 ACRIN Annual Meeting ULTIMATE GOAL Promote collaboration among departmental research team members by modeling a team approach to sharing “best practices” Large Group: Radiology Research Support Group Small Group: Trial Specific Small Group Meetings

11. Radiology Research Support Group Trial-specific Research Teams: - PIs - CRCs - RAs Research Administration & Radiology Department Chair ACRIN PIs & Contact Personnel © 2011 The University of Iowa Hospitals and Clinics Department of Radiology Conceptual design: Carol Mertens, Joe Ekdahl & Alan McGruder with assistance from the Radiology Research Support Group DCRC contact: e-mail: carol-mertens@uiowa.edu, phone: 319-384-9850 Departmental Clinical Research Coordinator & RA Support  Imaging  Data Management  Safety  Content Experts  Multi-disciplinary Research Personnel Accelerated Accrual Demonstration Project Collaborative Support Model The University of Iowa Department of Radiology

12. 2011 ACRIN Annual Meeting Demo Project: RESCUE RESCUE Status: –Member of “Rapid 10”—# 7!!! –“Most challenging site” –Launching Lunch: 28 JUN 2011 –First patient enrolled: 27 JUN 2011 –Two presentations at ACRIN

13. 2011 ACRIN Annual Meeting SELECTED OUTCOMES Small group team meeting format very helpful in trial start-ups Dubbed as “most challenging RESCUE site”— reflection of questions generated during RESCUE team meetings Mean days from submission to release of IRB approval below IRB average (68 vs.79).

14. 2011 ACRIN Annual Meeting U of I Full Board New Studies Mean Days: Submission to Release 2008-2010

15. 2011 ACRIN Annual Meeting SELECTED OUTCOMES RESCUE Rapid Ten: Site # 7 Fantastic teamwork, support, and interest in the Accelerated Accrual Project and RRSG! RRSG—Radiology Research Support Group –Great forum to exchange information and generate ideas!

16. 2011 ACRIN Annual Meeting Replication and Commitment Departmental Funding of DCRC Position: The Department of Radiology intends to provide partial funding for this position, employing a graduated budget which stipulates the following strategy for funding the DCRC salary: Year One: 65% ACRIN Accelerated Accrual Budget 35% Department of Radiology Supported Ends 12/31/2011 Year Two: 50 % Clinical Trials Supported 50% Department of Radiology Supported Department has committed to the second year Year Three: 75% Clinical Trials Supported 25% Department of Radiology Supported Department intends to fulfill 3 rd year commitment

17. 2011 ACRIN Annual Meeting ORIGINAL MOTTO A = ACRIN: T = TOGETHER E = EACH A = ACCOMPLISHES M = MORE

19. 2011 ACRIN Annual Meeting RESEARCH TEAMS FOSTER RESPONSIBILITY –Who does what? –Where are they in the process? –How can we support them? DIRECTION –Are we on the right track? –Are we moving toward the goal of the protocol?

20. 2011 ACRIN Annual Meeting RESEARCH TEAMS FOSTER OWNERSHIP –We all have a role/part in the study –The contributions and ideas provided by team members create ownership of project SOLIDARITY Brainstorming solutions as a team has promoted CAMARADERIE in both large and small research group settings.

21. 2011 ACRIN Annual Meeting Testimonials “Having a (DCRC) for (the RESCUE) study has taken the ethics workload away from our group so we are able to focus on recruitment, enrollment and retention.” –Kim Sprenger, CRC, RESCUE CRTeam Department of Internal Medicine University of Iowa Hospitals & Clinics

22. 2011 ACRIN Annual Meeting Testimonials “(The RESCUE project) truly is a great team effort and it is wonderful to have the collaborative support of (the U of I RESCUE) team and the ACRIN team!” –Janet Keating, Lead RA, RESCUE CRTeam Department of Internal Medicine University of Iowa Hospitals & Clinics

23. 2011 ACRIN Annual Meeting MOTTO ADDENDUM TEAM WORK IS BRAIN FOOD!!