1. CITI Administration Seattle, WA 10-5-07

2. 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

3. CITI Course Site Usage Statistics

4. 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

5. 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

6. 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

7. CITI Budget

8. CITI Course Site Performance HSR Satisfaction Survey Beta test 8-25-07 to 9-27-07

9. Which Human Subjects Protection Course(s) did you complete? Basic course for biomedical investigators.Basic course for biomedical investigators.29% Basic course for social & behavioral investigators.Basic course for social & behavioral investigators.53% A biomedical research Refresher Course.A biomedical research Refresher Course.8% A social & behavioral research Refresher Course.A social & behavioral research Refresher Course.10% N>11,000

10. Does your institution rely exclusively on the CITI Program to provide mandated instruction in the protection of human research subjects? Yes, The CITI Program is the only option available at my institution.Yes, The CITI Program is the only option available at my institution.71% No, my institution offers seminars, classes, or other options as an alternative to CITI.No, my institution offers seminars, classes, or other options as an alternative to CITI.29% N>11,000

11. Assuming a similar time commitment, would you prefer another vehicle for this mandated instruction? Yes, I would prefer a traditional classroom presentation.7% Yes, I would prefer an audio presentation.1% Yes, I would prefer a video presentation6% Yes, I would prefer a book or workbook tutorial format4% No, this web based approach suits me best.82% N>11,000

12. After completing the required modules, did you complete any of the optional modules? No, I did not complete any of the optional modulesNo, I did not complete any of the optional modules79% Yes, I completed a few optional modulesYes, I completed a few optional modules12% I completed all of the available optional modulesI completed all of the available optional modules9% N=11314

13. N=10691

14. How many log in sessions did you use to complete the curriculum requirements? 0% 5% 10% 15% 20% 25% 30% 35% FREQUENCY 1234567810 Login Sessions N>11,000

15. Course Site Usability - RCR N=212 N=214 N=213 N=214

16. N=178 Site Usability Lab Animal

17. Site Usability GCP N=125 Navigation through the CITI GCP Course was easy and intuitive Enrollment in the CITI GCP Course was easy and intuitive

19. N>11,000

20. I believe that the course I just completed will not only help me remain compliant with the Regulations and Policies, but, also help insure that I will be doing better science. 1 = Strongly disagree; 5 = Don't know; 9 = Strongly agree. n=11422

21. Now that I have completed the course, I am more confident in my ability to advise a student or a colleague on an issue of human subjects protection and the ethical conduct of human subjects research. 1 = Strongly disagree; 5 = Don't know; 9 = Strongly agree. N=11502

22. Now that I have completed this instruction in the protection of human research subjects, I intend to take a more active role in assuring that the research at my institution is conducted to the highest ethical standards. I intend to go to more seminars on human subjects issues, pursue professional certification (e.g., CIP), join an IRB / Research Ethics Committee or join a Data Safety Monitoring Board (DSMB) or take a course in Good Clinical Practice 1 = Strongly disagree; 5 = Don't know; 9 = Strongly agree. 42%

23. How would you rate the "The Basic Course in the Protection of Human Research Subjects 1 = Poor; 10 = Outstanding. N=10225

24. Refresher Courses Satisfaction Survey Beta test

25. If you just completed the Refresher course, did you take the CITI basic course previously? Yes, I took the basic course 1 yr ago.Yes, I took the basic course 1 yr ago.40% Yes, I took the basic course about 2 yrs agoYes, I took the basic course about 2 yrs ago29% Yes, I took the basic course about 3 yrs agoYes, I took the basic course about 3 yrs ago20% Yes, I took the basic course about 4 yrs agoYes, I took the basic course about 4 yrs ago6% Yes, I took the basic course 5 or more years agoYes, I took the basic course 5 or more years ago 5% 5% N=1949

26. I believe that ongoing instruction in human subjects protection for ALL members the research team is essential for assuring the ethical conduct of research with human research 1 = Strongly disagree; 5 = Don't know; 9 = Strongly agree. N=2471; REFRESHER ONLY

27. Looking back, I believe that the CITI Basic course, I completed previously, provided me with the ethical foundation to conduct my human subjects research to the highest ethical standards 1 = Strongly disagree; 5 = Don't know; 9 = Strongly agree. N=2412

28. Looking back, since completing the Basic Course I am more likely to have the confidence to engage in a discussion of human subjects protection or the ethical conduct of human subjects research with students and colleagues. 1 = Strongly disagree; 5 = Don't know; 9 = Strongly agree. N=2434

29. I would prefer to have more case studies in the Refresher Course. 1 = Strongly disagree; 5 = Don't know; 9 = Strongly agree. N=2537

30. Since completing the Basic CITI Course have you taken a more active role in protecting human subjects in reseaerch? 32% N=2817

31. Now that I have completed this instruction in the protection of human research subjects, I intend to take a more active role in assuring that the research at my institution is conducted to the highest ethical standards. I intend to go to more seminars on human subjects issues, pursue professional certification (e.g., CIP), join an IRB / Research Ethics Committee or join a Data Safety Monitoring Board (DSMB) or take a course in Good Clinical Practice 1 = Strongly disagree; 5 = Don't know; 9 = Strongly agree. 42% N>11,000

32. How would you rate the Refresher Course, overall ? 1 = Poor; 9 = Outstanding. N=2549

33. Friends of CITI

34. 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.

35. 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