1. CITI Course Site Updates Paul Braunschweiger Ph.D.

2. Update on CITI Software Implementation. Paul Braunschweiger Ph.D.

3. Course site Updates www.citiprogram.org; www.irbtraining.org www.citiprogram.orgwww.irbtraining.org www.citiprogram.orgwww.irbtraining.org Human SubjectsHuman Subjects –Basic and Refresher –Spanish versions GCPGCP –English, Spanish Lab AnimalLab Animal –Basic Courses –Species Specific Courses RCRRCR –Courses for 4 discipline –Public Access Health Information Privacy and Security (HIPS)Health Information Privacy and Security (HIPS) International Course SiteInternational Course Site –Public access

4. CITI Web Site Support Server CapacityServer Capacity –UM IT Server and Software consultants analyzed the configuration and code. 2000 concurrent users2000 concurrent users –Several server and software modifications since 5- 07. 2 New web servers added for load balancing (4).2 New web servers added for load balancing (4). Update ASP version.Update ASP version. Code optimization.Code optimization. –>1100 concurrent users. Safety limitation is 1500.Safety limitation is 1500. –2 nd Database server added for back-up. Hired a SQL database programmer (40%)Hired a SQL database programmer (40%)

5. 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 PARTICIPANTS 2000 TO 2007 1-Sept-06 800 700 1-April -07 900 1-Sept-07 832

6. 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; 8-25-07 to 9-27-07

7. 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; 8-25-07 to 9-27-07

8. User Satisfaction Surveys

9. CITI 2 Software Update Features, Modifications, and Planned Upgrades October 2007

10. What Does the CITI Software include? Tools to Create and modify coursework.Create and modify coursework. Create and modify quizzes.Create and modify quizzes. Design custom curricula for learners in each institution, depending on their research activities.Design custom curricula for learners in each institution, depending on their research activities. Design and administer surveys.Design and administer surveys. Help each learner track progress through their coursework.Help each learner track progress through their coursework. Provide institutional administrators with pertinent reports- who has completed the required training?Provide institutional administrators with pertinent reports- who has completed the required training? Monitor site usage (for site administrators).Monitor site usage (for site administrators).

11. CITI "2" Features as of January 2007 A single user account can be affiliated with multiple institutions.A single user account can be affiliated with multiple institutions. Learner can have multiple grade books (human subjects, RCR, animal research, etc) in each institution.Learner can have multiple grade books (human subjects, RCR, animal research, etc) in each institution. Enrollment questions are used to determine custom curriculum for each learner, per institutional wishes.Enrollment questions are used to determine custom curriculum for each learner, per institutional wishes. When learners earn a completion report, email can be sent to one or all institutional administrators.When learners earn a completion report, email can be sent to one or all institutional administrators.

12. One Learner Account, Multiple Institutions on the Main Menu Affiliate with another institution

13. Other Significant Enhancements Code continually rewritten to be more efficient and to support more concurrent users.Code continually rewritten to be more efficient and to support more concurrent users.

14. CITI 2 Features as of August 2007 In addition to training record set downloads available to institutional administrators, record sets can be downloaded automatically to local personnel management databases.In addition to training record set downloads available to institutional administrators, record sets can be downloaded automatically to local personnel management databases. Learners can be placed directly into the CITI Main Menu after learners login to the institution's host network, bypassing the usual CITI login process.Learners can be placed directly into the CITI Main Menu after learners login to the institution's host network, bypassing the usual CITI login process. Optionally, reminder emails sent to learners as completion reports expire.Optionally, reminder emails sent to learners as completion reports expire. Multiple learner accounts can be merged into one account (still undergoing beta testing).Multiple learner accounts can be merged into one account (still undergoing beta testing). Pre- and post-course completion surveys can be set up to collect feedback from learners.Pre- and post-course completion surveys can be set up to collect feedback from learners.

15. Automatic Downloads for Institutional Administrators- Record Set Formats Available (comma or tab-delimited files) All completion reports earned at the institution since ~January 2006 (+/- module names and quiz scores).All completion reports earned at the institution since ~January 2006 (+/- module names and quiz scores). Completion reports earned since the last dataset download (+/- module names and quiz scores).Completion reports earned since the last dataset download (+/- module names and quiz scores). Most recent completion report earned by each learner (+/- module names and quiz scores).Most recent completion report earned by each learner (+/- module names and quiz scores). Completion reports that will expire within 30, 60, 90, 120, or 180 days from today's date.Completion reports that will expire within 30, 60, 90, 120, or 180 days from today's date. Data fields in reports can be added or removed and sequenced as needed for each institution.

16. Same person ?? Direct Placement into the CITI Main Menu and Automatic Dataset Transfers to Institutions To 1) allow learners to use their institutional network username and password to enter the CITI main menu directly and 2) automate learner completion dataset transfers into local personnel management software the learner's institutional records and the learner's CITI records must share a unique identifier to ensure a perfect match. CITI Website -John Doe's records Local institutional training database -John Doe's records

17. Direct Learner Placement into the CITI Main Menu Reduced burden on learners and administratorsReduced burden on learners and administrators

18. Learner goes to CITI website and creates a username and password Learner chooses one or more institutions and provides contact and profile information Learner answers enrollment questions to create course grade books At Main Menu Learner completes coursework, earns completion report(s) Learner prints completion report(s), sends to admin office Admin office downloads records (email or dataset download) and enters data into local database Learner logs into local institutional network using their existing username and password Learner visits a local network page that collects profile and coursework information A unique learner ID is added, then data is encrypted and sent to CITI server to create a learner "session" CITI server automatically sends encrypted dataset to institution's server, unique ID used to merge dataset with local training database

19. Learner goes to CITI website and creates a username and password Learner chooses one or more institutions and provides contact and profile information Learner answers enrollment questions to create course grade books At Main Menu Learner completes coursework, earns completion report(s) Learner prints completion report(s), sends to admin office Admin office downloads records (email or dataset download) and enters data into local database Learner logs into local institutional network using their existing username and password Learner visits a local network page that collects profile and coursework information A unique learner ID is added, then data is encrypted and sent to CITI server to create a learner "session" CITI server automatically sends encrypted dataset to institution's server, unique ID used to merge dataset with local training database

20. University of Wisconsin Beta Test of Local Authentication and Direct Placement into CITI Main Menu Calvin Chang at UW providing coding and development support in collaboration with Stephanie Manuel and Chris Simmons (CITI programmers)Calvin Chang at UW providing coding and development support in collaboration with Stephanie Manuel and Chris Simmons (CITI programmers) Preliminary testing in September successful- proof of concept verifiedPreliminary testing in September successful- proof of concept verified Final coding and testing in late OctoberFinal coding and testing in late October Template will be available to all CITI institutionsTemplate will be available to all CITI institutions

21. University of Wisconsin Sample Screens

22. These links take a non- UW learner to the CITI home page

23. xxxxxxxxxxx

24. Once submitted, a unique ID and other profile info is sent to the CITI server and a learner "session" is set up.

25. In this case, the learner groups were not sent to the CITI server, so the learner must click to go to the enrollment questions to receive a curriculum.

26. The UW Learner now can be... Absolutely identified in dataset transfers from the CITI server to a UW server, because of the learner unique ID number shared by CITI and UW. A script can be written to automatically process the dataset received from CITI so that UW administrators do not have to spend time matching CITI and UW learner records. and...

27. Automatic Downloads for Institutional Administrators- Record Set Formats Available (comma or tab-delimited files) All completion reports earned at the institution since ~January 2006 (+/- module names and quiz scores).All completion reports earned at the institution since ~January 2006 (+/- module names and quiz scores). Completion reports earned since the last dataset download (+/- module names and quiz scores).Completion reports earned since the last dataset download (+/- module names and quiz scores). Most recent completion report earned by each learner (+/- module names and quiz scores).Most recent completion report earned by each learner (+/- module names and quiz scores). Completion reports that will expire within 30, 60, 90, 120, or 180 days from today's date.Completion reports that will expire within 30, 60, 90, 120, or 180 days from today's date. Data fields in reports can be added or removed and sequenced as needed for each institution.

28. User Interface and Site Usability Although overall ease of site navigation and registration process receive high survey satisfaction scores, about 15% of learners are dissatisfied with one or both.Although overall ease of site navigation and registration process receive high survey satisfaction scores, about 15% of learners are dissatisfied with one or both. Two focus areas for improvementTwo focus areas for improvement –Choosing affiliated institutions –Course enrollment process

29. Problems in Choosing Affiliated Institutions Some learners are confused by the multiple drop-down selection boxes, and believe they are supposed to choose one institution from each category. A redesigned process is needed.Some learners are confused by the multiple drop-down selection boxes, and believe they are supposed to choose one institution from each category. A redesigned process is needed.

30. Difficulty in Navigating the Enrollment Questions Some learners have a difficult time navigating through the enrollment questions.Some learners have a difficult time navigating through the enrollment questions. Some specific challenges:Some specific challenges: –Currently, all learners have to see all enrollment questions. –Some institutions have 10 or more enrollment questions that all appear on one page. –It can be difficult for learners to understand which questions they should answer.

31. Solution- One Enrollment Question per Page Q1 (ID#233). Which of the following apply to your research activities? Human subjects research. [if chosen, turns on Q#234; no groups associated] Animal research. [if chosen, turns on Q#245; no groups associated] Use of hazardous agents in research. [if chosen, turns on Q#250; no groups associated] Q4 (ID#245).Do you serve on the IACUC? Yes. [Essentials for IACUC Members; stage 1] No. Q2 (ID#234). Which of the following apply to your human research activities? Biomedical studies. [if chosen, turns on Q#235; no groups associated] Social or Behavioral studies. [CITI Social and Behavioral Course; stage 1] GCP. [CITI GCP Course; stage 1]\ Q3 (ID#235).Do you need to take the Basic or Refresher Biomed Course? Basic (stage 1). [CITI Biomedical Course; stage 1] Refresher (stage 2). [CITI Biomed Course; stage 2] Q5 (ID#250).Do you work with select agents? Yes. [Select Agent Training; stage 1 and Basic Biosafety; stage 1] No. [Basic Biosafety; stage 1] (Skipped ) DONE

32. Q1 (ID#233). Which of the following apply to your research activities? Human subjects research. [if chosen, turns on Q#234; no groups associated] Animal research. [if chosen, turns on Q#245; no groups associated] Use of hazardous agents in research. [if chosen, turns on Q#250; no groups associated] Q4 (ID#245).Do you serve on the IACUC? Yes. [Essentials for IACUC Members; stage 1] No. Q2 (ID#234). Which of the following apply to your human research activities? Biomedical studies. [if chosen, turns on Q#235; no groups associated] Social or Behavioral studies. [CITI Social and Behavioral Course; stage 1] GCP. [CITI GCP Course; stage 1]\ Q3 (ID#235).Do you need to take the Basic or Refresher Biomed Course? Basic (stage 1). [CITI Biomedical Course; stage 1] Refresher (stage 2). [CITI Biomed Course; stage 2] Q5 (ID#250).Do you work with select agents? Yes. [Select Agent Training; stage 1 and Basic Biosafety; stage 1] No. [Basic Biosafety; stage 1] (Skipped) DONE

33. Q1 (ID#233). Which of the following apply to your research activities? Human subjects research. [if chosen, turns on Q#234; no groups associated] Animal research. [if chosen, turns on Q#245; no groups associated] Use of hazardous agents in research. [if chosen, turns on Q#250; no groups associated] Q4 (ID#245).Do you serve on the IACUC? Yes. [Essentials for IACUC Members; stage 1] No. Q2 (ID#234). Which of the following apply to your human research activities? Biomedical studies. [if chosen, turns on Q#235; no groups associated] Social or Behavioral studies. [CITI Social and Behavioral Course; stage 1] GCP. [CITI GCP Course; stage 1]\ Q3 (ID#235).Do you need to take the Basic or Refresher Biomed Course? Basic (stage 1). [CITI Biomedical Course; stage 1] Refresher (stage 2). [CITI Biomed Course; stage 2] Q5 (ID#250).Do you work with select agents? Yes. [Select Agent Training; stage 1 and Basic Biosafety; stage 1] No. [Basic Biosafety; stage 1] (Skipped) DONE (Skipped)

34. Ongoing Feature Enhancements Conversion of entire website to support "on the fly" foreign language translation of web pages (testing nearly complete)Conversion of entire website to support "on the fly" foreign language translation of web pages (testing nearly complete) Conversion of entire website from ASP pages to ASP.Net pages.Conversion of entire website from ASP pages to ASP.Net pages. Sophisticated code to check and alert a learner when a learner's previous coursework suggests that they should be in a different course or course stage than what their enrollment question choices would suggest.Sophisticated code to check and alert a learner when a learner's previous coursework suggests that they should be in a different course or course stage than what their enrollment question choices would suggest. Solve the problems related to transferring completion credits between organizations.Solve the problems related to transferring completion credits between organizations. Implement additional tools for the CITI Office staff to speed set-ups.Implement additional tools for the CITI Office staff to speed set-ups. Implement additional survey tools and utilitiesImplement additional survey tools and utilities

35. Updates from Executive Advisory Committee (EAC) - Ernie Prentice Ph.D.

36. Final CITI Structure and Processes Documents Karen Hansen

37. CITI Newsletter Susan Rose Ph.D.

38. Biomedical Course Update Sally Mann

39. Social and Behavioral Course Update Lorna Hicks

40. International Research Platform Updates Karen Hansen & Michel Eckersley

41. International Collaborations and Demonstration Projects Paul Braunschweiger Ph.D.

42. International Collaborations and Demonstration Projects IntroductionIntroduction Update on Canadian CITI – Laura-Lee Balkwill, Denise StockleyUpdate on Canadian CITI – Laura-Lee Balkwill, Denise Stockley Update of Taiwan Program – Benjamin KuoUpdate of Taiwan Program – Benjamin Kuo Update of Africa Program – Ifeoma OkoyeUpdate of Africa Program – Ifeoma Okoye Latin America/South America – Sergio Litewka, Mario Tristan, Roxana Lescano and Carla DeSousaLatin America/South America – Sergio Litewka, Mario Tristan, Roxana Lescano and Carla DeSousa Spanish Language Course SiteSpanish Language Course Site

43. Update on CITI Canada Laura-Lee Balkwill, Denise Stockley

44. Update of CITI Taiwan Benjamin Kuo MD

45. Update of Africa Program Ifeoma Okoye MD

46. Update of CITI Latin America/South America Sergio Litewka, Mario Tristan, Roxana Lescano and Carla deSousa

47. CITI Worldwide Footprint

48. CITI Non-English Language Course Site Funding from NAIDS June 2007 to translate GCP Course to Spanish.Funding from NAIDS June 2007 to translate GCP Course to Spanish. Vendor problems to overcome.Vendor problems to overcome. Technical problems to overcome.Technical problems to overcome.

49. Spanish and Portuguese Language Course Sites