CITI Program History and CITI Program History and OverviewOverview

Paul Braunschweiger Ph.D.Paul Braunschweiger Ph.D.

CITI Co-FounderCITI Co-Founder

Chair, U of Miami IACUCChair, U of Miami IACUC

June 2000 DHHS Mandates Training in June 2000 DHHS Mandates Training in Human Subjects ProtectionHuman Subjects Protection

March 2000March 2000Collaborative Institutional Training Initiative (CITI)Collaborative Institutional Training Initiative (CITI)

10 Initial Collaborating Organizations10 Initial Collaborating Organizations

What is the CITI Program?What is the CITI Program?

• CITI is a volunteer organization whose goal is to CITI is a volunteer organization whose goal is to develop and distribute high quality, peer reviewed develop and distribute high quality, peer reviewed educational resources designed to raise awareness educational resources designed to raise awareness to the Responsible Conduct of Research for all to the Responsible Conduct of Research for all members of the research team.members of the research team.

• CITI maintains an educational website where CITI maintains an educational website where participating organizations can design and roll out a participating organizations can design and roll out a customized curriculum for their investigators, customized curriculum for their investigators, students staff and administrators. students staff and administrators.

www.citiprogram.org

CITI – ProgramCITI – Program 10-200710-2007

CITI Administration – Office of Research Education, University of MiamiCITI Administration – Office of Research Education, University of MiamiUniversity of Miami Medical Information Technology University of Miami Medical Information Technology

Participating Institutions and Organizations (~832)Participating Institutions and Organizations (~832)

CITI Developer Group (~55)CITI Developer Group (~55)

CITI Editorial Board (15)CITI Editorial Board (15)

Intl.Intl.

GCPGCP

RCRRCR

TaiwanCaribbean

Brazil

Latin America

Africa

C.R.

CITI Executive Advisory CommitteeCITI Executive Advisory Committee

HSRPHSRP

Founders

CanadaCanada

L.A.W.L.A.W.

CITI “Help Desk”CITI “Help Desk”• Resolve learner problemsResolve learner problems

– RegistrationsRegistrations

– Technical IssuesTechnical Issues

• Institution set up supportInstitution set up support– Program CurriculumProgram Curriculum

– Institutional page setupInstitutional page setup

• Coordinator SupportCoordinator Support– Changes in contact Changes in contact

informationinformation

– Implement Modifications.Implement Modifications.

– Report UtilitiesReport Utilities

305 243-7970citisupport@med.miami.edu

CITI Administration 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

CITI CoursesCITI Courses

• Human Subjects ProtectionHuman Subjects Protection– Biomedical SciencesBiomedical Sciences– Social and behavioral Sciences Social and behavioral Sciences – International ResearchInternational Research

• Good Clinical Practice & ICHGood Clinical Practice & ICH– 14 modules14 modules

• HIPSHIPS– 18 modules18 modules

• Lab Animal WelfareLab Animal Welfare– Basic CoursesBasic Courses– Species Specific CoursesSpecies Specific Courses

• Responsible Conduct of Responsible Conduct of ResearchResearch– 105 modules and case studies105 modules and case studies– 4 Disciplines4 Disciplines

The Role of the VA in CITI Development The Role of the VA in CITI Development and Success.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 Joan Porter Ph.D. and David Miller Ph.D. provided content and financial

support.support.– Marisue Cody Ph.D., Dir. COACH also became involved in the CITI Program Marisue Cody Ph.D., Dir. COACH also became involved in the CITI Program

• Software DevelopmentSoftware Development– 2003 collaboration with Mike Fallon DVM, Atlanta VA2003 collaboration with Mike Fallon DVM, Atlanta VA– May 2004 May 2004 www.citiprogram.org – Jan. 2007 Jan. 2007 www.citiprogram.org ver 2.0 ver 2.0

• 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.

The Role of the VA in CITI Development The Role of the VA in CITI Development and Success.and Success.

• Software DevelopmentSoftware Development– June 2007 CITI adopts the VA Lab animal Training program at June 2007 CITI adopts the VA Lab animal Training program at

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. October 2007 Non- English capabilities. • Friends to the CITI ProgramFriends to the CITI Program

– VAVA– DoEDoE– ORIORI– OHRPOHRP– NavyNavy– FHCRCFHCRC– U of MiamiU of Miami

CITI Program GrowthCITI Program Growth

00

100100

200200

300300

400400

500500

600600

PA

RT

ICIP

AT

ING

OR

GA

NIZ

AT

ION

SP

AR

TIC

IPA

TIN

G O

RG

AN

IZA

TIO

NS

1-Aug-00

17-Apr-01

15-Aug-02

13-Aug-03

15-Aug-04

1-Aug-05

CITI ORGANIZATIONS 2000 TO 2007CITI ORGANIZATIONS 2000 TO 2007

1-Sept-06

800800

700700

1-April -07

900900

1-Sept-07

832832

Monthly Site UsageMonthly Site UsageCITI Monthly ActivitiesCITI Monthly Activities

00

5,0005,000

10,00010,000

15,00015,000

20,00020,000

25,00025,000

30,00030,000

MayMay

August

August

Novem

ber

Novem

ber

Febru

ary

Febru

ary

MayMay

August

August

Novem

ber

Novem

ber

Febru

ary

Febru

ary

MayMay

August

August

Novem

ber

Novem

ber

Febru

ary

Febru

ary

Reg

istr

ants

Reg

istr

ants

and

Cou

rse

and

Cou

rse

Com

plet

ions

Com

plet

ions

MayMay

August

August

Novem

ber

Novem

ber

2004200420072007

35,00035,000

CITI Worldwide FootprintCITI Worldwide Footprint

Lab. Animal Welfare Course Lab. Animal Welfare Course Learner Satisfaction Survey Learner Satisfaction Survey

8-25-07 to 9-27-07220-150 Responders

CITI Course Completions CITI Course Completions 4-1-07 to 10-1-074-1-07 to 10-1-07

• HSR Basic and Refresher Courses 128,523

• Lab Animal Welfare 5,926

• RCR ~2,700

• Good Clinical Practice 2,074

• HIPS 762

Total 140,005

Completed CoursesCompleted Courses

Lab Animal Course Usage Lab Animal Course Usage 4-1-07 to 10-1-074-1-07 to 10-1-07

• General Investigator Training 2450

• IACUC Member Training 389

• Post Procedural Care 469

• Species Specific Training 2618

Total 5926

Completed CoursesCompleted Courses

User Satisfaction SurveyUser Satisfaction Surveyn=174n=174

60%60% Use CITI OnlyUse CITI Only

65%65% Students and staffStudents and staff

>70%>70% Prefer the web based approach to other training Prefer the web based approach to other training

paradigmsparadigms

High degree of concurrence that the training is High degree of concurrence that the training is necessarynecessary

0%5%

10%

15%

20%

25%

30%

35%

40%

45%

FR

EQ

UE

NC

Y

1 2 3 4 5 6 7 8 9

RATING

It was easy to register and enroll in the appropriate course. 1= Strongly disagree; 9 =

Strongly agree

0%

5%

10%15%

20%

25%

30%

35%40%

45%

50%

FR

EQ

UE

NC

Y

1 2 3 4 5 6 7 8 9

RATING

Course site navigation was easy and intuitive. 1 = Strongly disagree; 9 = Strongly agree

N=178

Enrollment & NavigationEnrollment & Navigation

11%

0%5%

10%15%20%25%30%35%

FR

EQ

UE

NC

Y

1 2 3 4 5 6 7 8 9

RATING

1 = Strongly disagree; 5 = Don't know; 9 = Strongly agree.

N=175

After completing this instruction, I now have a better understanding of After completing this instruction, I now have a better understanding of how to apply the "3Rs" to insure that my lab animal studies are how to apply the "3Rs" to insure that my lab animal studies are

conducted to the highest ethical standards? conducted to the highest ethical standards?

0%

5%

10%

15%

20%

25%

30%

FR

EQ

UE

NC

Y

1 2 3 4 5 6 7 8 9

RATING

1 = Strongly disagree; 5 = Don't know; 9 Strongly agree

N=174

Now that I have completed the course, I am more confident in my 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 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 insure that their lab animal studies are conducted to the highest ethical standards?standards?

0%

5%

10%

15%

20%

25%

30%

FR

EQ

UE

NC

Y

1 2 3 4 5 6 7 8 9

RATING

N=172

After completing this instruction on the ethical conduct of studies with laboratory 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 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 at my institution is conducted to the highest ethical standards by pursuing professional certification or by joining the IACUC.professional certification or by joining the IACUC.

0%

5%

10%

15%

20%

25%

30%

FR

EQ

UE

NC

Y

1 2 3 4 5 6 7 8 9

RATING

How would you rate the "Working with the IACUC Course"? 1 = Poor, 5 = Average; 9 = Outstanding.

N=158

0%

5%

10%

15%

20%

25%

FR

EQ

UE

NC

Y

1 2 3 4 5 6 7 8 9

RATING

How would you rate the the "Essentials for IACUC Members" 1 = Poor, 5 = Average; 9 = Outstanding.

N=93

0%

5%

10%

15%

20%

25%

30%

FR

EQ

UE

NC

Y

1 2 3 4 5 6 7 8 9

RATING

How would you rate the Species Specific module (e.g., "Working With Mice in The Research Setting) you completed? 1

= Poor, 5 = Average; 9 = outstanding.

N=91

• 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 Express good intentions regarding future behavior

and involvement in Lab Animal Welfare.and involvement in Lab Animal Welfare.• Some written commentsSome written comments

– Too long, to redundant, poor quiz questions, enrollment Too long, to redundant, poor quiz questions, enrollment procedure.procedure.

• We have a great start. We have a great start. – Thankfully, there is room for improvement.Thankfully, there is room for improvement.

SummarySummary

CITI Program OverviewCITI Program Overview

Paul Braunschweiger Ph.D.Paul Braunschweiger Ph.D.

CITI Co-FounderCITI Co-Founder

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 CourseLab Animal Welfare Course

N=375

0% 5% 10% 15% 20% 25% 30% 35% 40%

Frequency

GerbilsCats

Guinea PigsAmphibians

HamstersNon-Human Primates

DogsSwine

RabbitsPain and Distress

RatsEssentials for IACUC Members

MiceWorking with the IACUC

Modules completed

Which Modules Where Most Frequently Which Modules Where Most Frequently CompletedCompleted

N=361

What is your current role in research?

0% 5% 10% 15% 20% 25% 30% 35%

Research Integrity Officer

Research Advisor

Compliance Coordinator

Faculty Mentor

Post-Doctoral Fellow

Research Administrator

Laboratory Research Staff

Ph.D. Student

Faculty Investigator

Masters Student

Undergraduate Student

Frequency

0%

5%

10%

15%

20%

25%

30%

FR

EQ

UE

NC

Y

1 2 3 4 5 6 7 8 9

RATING

If you have previously completed a Lab Animal Welfare course, How does this CITI Course compare with others you have completed?

1 = By far the worst; 5 = About the same as the others; 9 = By far the best.

N=156, 49 did not previously take a course