1. 10-4-2007 CITI Program History and Overview Paul Braunschweiger Ph.D. CITI Co-Founder Chair, U of Miami IACUC

2. 10-4-2007 June 2000 DHHS Mandates Training in Human Subjects Protection March 2000 Collaborative Institutional Training Initiative (CITI) 10 Initial Collaborating Organizations

3. 10-4-2007 What is the CITI Program? CITI is a volunteer organization whose goal is to develop and distribute high quality, peer reviewed educational resources designed to raise awareness to the Responsible Conduct of Research for all members of the research team.CITI is a volunteer organization whose goal is to develop and distribute high quality, peer reviewed educational resources designed to raise awareness to the Responsible Conduct of Research for all members of the research team. CITI maintains an educational website where participating organizations can design and roll out a customized curriculum for their investigators, students staff and administrators.CITI maintains an educational website where participating organizations can design and roll out a customized curriculum for their investigators, students staff and administrators. www.citiprogram.org

4. 10-4-2007 CITI – Program 10-2007 CITI Administration – Office of Research Education, University of Miami University of Miami Medical Information Technology Participating Institutions and Organizations (~832) CITI Developer Group (~55) CITI Editorial Board (15) Intl. GCP RCR Taiwan Caribbean Brazil Latin America Africa C.R. CITI Executive Advisory Committee HSRP Founders Canada L.A.W.

5. 10-4-2007 CITI “Help Desk” Resolve learner problemsResolve learner problems –Registrations –Technical Issues Institution set up supportInstitution set up support –Program Curriculum –Institutional page setup Coordinator SupportCoordinator Support –Changes in contact information –Implement Modifications. –Report Utilities 305 243-7970 citisupport@med.miami.edu

6. 10-4-2007 CITI Administration 4+ FTE in the Office –Adiper Santos – Office Manager –Marcos Souza - Help Desk Technician –Eddie Menjivar - Help Desk Technician –Regina Smith - Help Desk Technician –Chris Simmons – Programmer (40%) –2 TBN - Help Desk Technician (October 2006) Moving to a bigger office suite in November

7. 10-4-2007 CITI Courses Human Subjects ProtectionHuman Subjects Protection –Biomedical Sciences –Social and behavioral Sciences –International Research Good Clinical Practice & ICHGood Clinical Practice & ICH –14 modules HIPSHIPS –18 modules Lab Animal WelfareLab Animal Welfare –Basic Courses –Species Specific Courses Responsible Conduct of ResearchResponsible Conduct of Research –105 modules and case studies –4 Disciplines

8. 10-4-2007 The Role of the VA in CITI Development and Success. VA was an early (2002) supporter of the CITI Program.VA was an early (2002) supporter of the CITI Program. –Joan Porter Ph.D. and David Miller Ph.D. provided content and financial support. –Marisue Cody Ph.D., Dir. COACH also became involved in the CITI Program Software DevelopmentSoftware Development –2003 collaboration with Mike Fallon DVM, Atlanta VA –May 2004 www.citiprogram.org www.citiprogram.org –Jan. 2007 www.citiprogram.org ver 2.0 www.citiprogram.org Multiple course presentations and Refresher coursesMultiple course presentations and Refresher courses Better registration and Admin. UtilitiesBetter registration and Admin. Utilities Flexible presentation paradigms.Flexible presentation paradigms. Foreign language capabilities.Foreign language capabilities. One stop shopping for compliance training.One stop shopping for compliance training.

9. 10-4-2007 The Role of the VA in CITI Development and Success. Software DevelopmentSoftware Development –June 2007 CITI adopts the VA Lab animal Training program at www.researchtraining.org. www.researchtraining.org Major software retooling requiredMajor software retooling required Development if utilities to transfer user records from RT to CITI.Development if utilities to transfer user records from RT to CITI. Content modifications.Content modifications. Trouble shooting and fixing troublesome code incompatibilities.Trouble shooting and fixing troublesome code incompatibilities. –October 2007 Non- English capabilities. Friends to the CITI ProgramFriends to the CITI Program –VA –DoE –ORI –OHRP –Navy –FHCRC –U of Miami

10. 10-4-2007 CITI Program Growth 0 100 200 300 400 500 600 PARTICIPATING ORGANIZATIONS 1-Aug-00 17-Apr-01 15-Aug-0213-Aug-0315-Aug-04 1-Aug-05 CITI ORGANIZATIONS 2000 TO 2007 1-Sept-06 800 700 1-April -07 900 1-Sept-07 832

11. 10-4-2007 Monthly Site Usage CITI Monthly Activities 0 5,000 10,000 15,000 20,000 25,000 30,000 May August November February May August November February May August November February Registrants and Course Completions May August November 2004 2007 35,000

12. 10-4-2007 CITI Worldwide Footprint

13. 10-4-2007 Lab. Animal Welfare Course Learner Satisfaction Survey 8-25-07 to 9-27-07 220-150 Responders

14. 10-4-2007 CITI Course Completions 4-1-07 to 10-1-07 HSR Basic and Refresher Courses128,523 Lab Animal Welfare 5,926 RCR~2,700 Good Clinical Practice2,074 HIPS762 Total140,005 Completed Courses

15. 10-4-2007 Lab Animal Course Usage 4-1-07 to 10-1-07 General Investigator Training2450 IACUC Member Training389 Post Procedural Care469 Species Specific Training2618 Total5926 Completed Courses

16. 10-4-2007 User Satisfaction Survey n=174 60% Use CITI Only Use CITI Only 65% Students and staff Students and staff >70% Prefer the web based approach to other training paradigms Prefer the web based approach to other training paradigms High degree of concurrence that the training is necessary High degree of concurrence that the training is necessary

17. 10-4-2007 N=178 Enrollment & Navigation 11%

18. 10-4-2007 N=175 After completing this instruction, I now have a better understanding of how to apply the "3Rs" to insure that my lab animal studies are conducted to the highest ethical standards?

19. 10-4-2007 N=174 Now that I have completed the course, I am more confident in my ability to advise a student or a colleague on how to apply the "3Rs" to insure that their lab animal studies are conducted to the highest ethical standards?

20. 10-4-2007 N=172 After completing this instruction on the ethical conduct of studies with laboratory animals, I intend to take a more active role in assuring that lab animal research at my institution is conducted to the highest ethical standards by pursuing professional certification or by joining the IACUC.

21. 10-4-2007 N=158

22. 10-4-2007 N=93

23. 10-4-2007 N=91

24. 10-4-2007 Course seems to be well acceptedCourse seems to be well accepted Enrollment and Navigation is an issue for some.Enrollment and Navigation is an issue for some. Learners indicated that they learned something.Learners indicated that they learned something. Express good intentions regarding future behavior and involvement in Lab Animal Welfare.Express good intentions regarding future behavior and involvement in Lab Animal Welfare. Some written commentsSome written comments –Too long, to redundant, poor quiz questions, enrollment procedure. We have a great start.We have a great start. –Thankfully, there is room for improvement. Summary

25. 10-4-2007 CITI Program Overview Paul Braunschweiger Ph.D. CITI Co-Founder

26. 10-4-2007

27. 0%2%4%6%8%10%12%14%16%18% Frequency Pain Category E Studies Interventional Field Studies Investigational Device testing Gene Therapy Studies with Tumor Bearing Animals Investigational Drug toxicity or Genetic Modification of Animals Immunization, Antibody Production, Observational Field Studies Major Survival Surgery Behavioral Studies Non-Survival Surgery Minor Survival Surgery Tissue Harvest After Euthanasia, Investigational Procedures Used Lab Animal Welfare Course N=375

28. 10-4-2007 0%5%10%15%20%25%30%35%40% Frequency Gerbils Cats Guinea Pigs Amphibians Hamsters Non-Human Primates Dogs Swine Rabbits Pain and Distress Rats Essentials for IACUC Members Mice Working with the IACUC Modules completed Which Modules Where Most Frequently Completed N=361

29. 10-4-2007

30. N=156, 49 did not previously take a course