1. Clinical and Translational Science Awards (CTSA) Anthony Hayward October 30, 2007

2. Vision for the CTSA Program  Strengthen Clinical Research as an academic discipline by creating a ‘home’ and a career structure.  Support the clinical and translational researcher through provision of resources that are most needed.  Speed clinical and translational research through resource and data sharing.  Advance the safety and quality of research through adoption of good clinical practices and effective use of informatics.

3. Trial Design Advanced Degree-Granting Programs Participant & Community Involvement Regulatory Support Biostatistics Clinical Resources Biomedical Informatics Clinical Research Ethics CTSAHOME NIH & other government agencies Healthcare organizations Industry Each academic health center will create a home for clinical and translational science

4. MT WY ID WA OR NV UT CA AZ ND SD NE CO NM TX OK KS AR LA MO IA MN WI IL IN KY TN MS AL GA FL SC VA WV OH MI NY PA MD DE NJ CT RI MA ME VT NH AK HI Building a National CTSA Consortium Since 2006 Since 2007 Participating Institutions

5. The transformation process In 2005, 66 universities were associated with 78 GCRCs where 14,760 investigators had 9257 protocols: 3245 publications were reported By 2011 NCRR expenditure on clinical research infrastructure will rise to $500M from $333M. Infrastructure/training support increase by ~ 40% Transformation to integrated consortium GCRCs had Research Subject Advocates – CTSAs designate their own preferred individual.

6. Organization of CTSAs Include an institution that can award higher degrees in clinical research Include research education and career development activities Cooperative agreements ensure that awardees work together as a consortium CTSAs send representatives to steering committees and workgroups

7. Consortium Governance & Organization Governance Manual available at http://ctsaweb.org/Docs/CTSA_Governance_Manual.pdf http://ctsaweb.org/Docs/CTSA_Governance_Manual.pdf

8. CTSA Steering Committees and Workgroups Embody the expertise of the Consortium Provide a forum for dialogue with the NIH Identify needs, goals and priorities Serve as a platform to adopt common standards Have deliverables and timetables

9. Alternative IRB models workgroup Created to: Identify conditions favorable for pilot projects to test alternative IRB models Share experience with regional reciprocity and common IRBs Promote common consent language Develop metrics and identify roadblocks Address IRB differences e.g., in pediatrics

10. CTSAWeb.org