Yale Clinical Research Management Changes 2008 to Present Day

1. Yale Clinical Research Management Changes2008 to Present Day Tesheia H. Johnson, MBA, MHS Associate Director for Clinical Research Yale University School of Medicine Secretary’s Advisory Committee on Human Research Protections October 19, 2010

2. Yale University, New Haven, Connecticut

3. Our Process and Progress: • CTSA Clinical Research Management Workshop - June 23-24, 2008 • You can improve without a baseline • CTSA Clinical Research Management Workshop - June 22-23, 2009 • We measured, we were not that good, now how do we improve • CTSA Clinical Research Management Workshop - June 21-22, 2010 • Keep it going – What is beyond the IRB and contracting • CTSA Clinical Research Management Workshop - June 20-21, 2011 • Horizon: More IT tools…EPIC, Clinical Research Management System, Data Repository

4. Improved Research Approval Timeline

5. Improved Research Approval Timeline • These improvements are due to major changes in the review process, support of the Yale IRB, the addition of experienced regulatory staff working with the investigator to prepare better submissions, and the start of the implementation of the new Coeus IRB electronic system for protocol approvals. • ORS has maintained a rate of 40-45 day turn around for the past two years for ~100-160 projects per year

6. 35 DAYS SAVED!!…Two years and counting Challenges • Effecting enterprise wide change in the silo culture • Longstanding structures: “Former GCRC”…we have always done it this way • Natural tendency to look outward toward others (IRB/Grants and Contracts) for change instead of critically examining internal processes Successes • All stakeholders joined forces overcoming cultural barriers • Redundancies were reduced • Learn from others: • “No value add=Delete • Science writer • Success breeds enthusiasm and support for maintaining change

7. Collaborations Protocol Review and Monitoring

8. Mayo Grant Application Yale Grant Application Exporting Yale knowledge, expertise and support models to Mayo Clinic Exporting Mayo Clinic knowledge, expertise and support models to Yale • Mayo will assist YCCI with strengthening its FDA regulatory support to investigators. • Mayo will assist YCCI with minority inclusion, health disparities and community engagement efforts. • Mayo will assist YCCI with development of web-based tracking and reporting tools. • Mayo will assist YCCI with education and training of study coordinators. • Assessing and adapting the YCCI ORS support model to enhance and further develop the Mayo CTSA Service Center. • Assessing needs and feasibility of adapting the YCCI ORS study coordinator service model to support Mayo clinical and translational researchers. • Assessing the feasibility of adapting the Yale University-Community Practice research Affiliate program to support Mayo clinical and translational researchers. Importing Mayo Clinic knowledge, expertise and support models to Yale Importing Yaleknowledge, expertise and support models to Mayo Clinic • Assessing needs and feasibility of adapting the Mayo IND/IDE support model to Yale or Sub-contracting support for Yale clinical and translational researchers. • Assessing needs and feasibility of adapting the Mayo Clinic service model for patient recruitment and retention strategies, including disparities outreach in support Yale-based clinical and translational research activities. • Assessing feasibility of adapting the Mayo Clinic developed novel clinical research management technologies to support Yale-based research activities. • Assessing feasibility adapting the Mayo Clinic developed education program to support training for Yale regulatory and study coordination staff. • YCCI will assist Mayo with transforming CTSA Service Center per the model of YCCI Office of Research Services (ORS). • YCCI will assist Mayo with assess need/feasibility of developing a study coordinator pool. • YCCI will assist Mayo with the development of a Community Research Site Toolkit based on YCCI model.