CITI: Collaborative Institutional Training Initiative

MCW requires individuals involved in the design, conduct or review of human subject research to have current Human Subject Research Protections training. MCW utilizes the CITI Program to provide Human Subject Research Protections training for biomedical researchers, social/behavioral researchers and research reviewers.

CITI Requirements

• Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW IRBs or another authorized IRB must obtain CITI certification.
• New employees must complete the required modules and obtain CITI certification prior to starting any human subject research work.
• Members of the human subject research team, including the Principal Investigator (PI), must have current certification.
• Initial CITI certification is obtained by completing the required online modules and one elective module with an overall score of 80%. The initial CITI course can be completed in four to six hours. Six CE credits are available from CITI for purchasing by the individual.
• In order to maintain CITI certification, everyone is required to complete the CITI Refresher course every three (3) years after initial certification is obtained. Completion of the refresher modules can usually be completed in less than two hours.

CITI Offerings: 

• Biomedical Research
• Biomedical Research + Good Clinical Practices
• Social Behavioral Research 

Go to CITI Website

Biomedical involves all types of clinical research studies, including FDA-regulated research and those that involve investigational drugs, biologics, and devices.

Investigational devices encompass a wide variety of items. The following are examples which would be considered investigational devices:

• Non-FDA cleared devices (both implantable or one which will be applied to just the surface of the body)
• Investigational software packages which will be run on a FDA cleared device (such as WIP MR pulse sequences, or post-processing analysis software);
• In-vitro diagnostic assays (IVD), laboratory developed tests (LDTs);
• Certain types of mobile applications which will provide a clinical decision (without physician or provider input)

This course is accessed through the CITI Training Website and is listed as the Biomedical Learner Group in CITI.

Course Instructions: 

1. Go to citiprogram.org or click the link below.
2. Enter the username and password used to register with the CITI Program.
3. On the Main Menu Page, click on Biomedical Learner Group to begin. 
4. Complete the Integrity Assurance Statement. 
5. Complete the required modules and associated quizzes and one elective module and quiz. You may re-review the modules and repeat any quizzes to attain the overall passing score of 80%. (Once you have completed all of the required modules in your curriculum you will be shown optional modules which may be completed at a future time. 
6. Upon successful completion of the modules and associated quizzes, save a copy of your completion report for your records.

For Technical Support: 
Contact eBridge Help Desk

Go to CITI Website

The NIH and its Institutes recognize that translation of novel drugs and devices requires a well-trained research workforce. The National Center for Advancing Translational Science (NCATS) as part of its mission to improve the quality of clinical and translational research nationally has initiated a series of innovative programs that make Clinical and Translational Science Award hubs and partner organizations great places to conduct high quality research. The leadership at the Medical College of Wisconsin and the Clinical and Translational Science Institute of Southeast Wisconsin (CTSI), embrace these high standards and training for our researchers. We believe that the addition of Good Clinical Practice (GCP) training will equip study personnel with the necessary and fundamental competencies to conduct FDA regulated clinical research.

CTSI GCP Training Requirements
MCW offers Good Clinical Practices (GCP) courses through Collaborative Institutional Training Initiative (CITI). MCW faculty and staff engaged in FDA regulated research that fit the following criteria are required to complete GCP training:

• Studies that involve the use of any drug or biologic therapy (including botanicals, dietary supplements, medical foods, etc.) for purposes other than routine clinical care (including physiological challenge tests)
• Safety or efficacy evaluations of any apparatus that the FDA does or might consider to be a “medical device"
• Safety or efficacy evaluation of any type of diagnostic test (including “in vitro” diagnostic tests, or “companion” / “complementary” (usually genetic) diagnostic tests).
• Any study where the results will be submitted at a later date to the FDA in support of some drug, biologic, medical device, or in vitro diagnostic test application.
• CTSI‐funded studies including Translational Research Unit and Imaging Center studies that are FDA regulated.
• Protocols submitted to IRB that used CTSI Biostatistics Research Design consultation that are FDA regulated.

About GCP CITI Training

• Completion of GCP training may require three - six hours.
• The NIH requires a 3‐year refresher of GCP training. 
• Refer to the CTSI and MCW GCP Research Training Requirement - FAQ (PDF)
• In case of questions regarding GCP training, please contact Amit Gode, (414) 805-6999.

NOTE: GCP training by the Association of Clinical Research Professionals (ACRP) or from other accredited sources including industry based programs during the past three years is an acceptable alternative to CITI GCP training. Please provide documentation of the organization providing training, topics covered, hours to complete it, and contact person at the organization to Amit Gode.

Course instructions: 

1. Go to citiprogram.org or click the link below.
2. Enter username and password used to register with the CITI Program.
3. On the Main Menu Page, click on Biomedical + GCP Learner Group to begin. 
4. Complete the Integrity Assurance Statement. 
5. Complete the required modules and associated quizzes and one elective module and quiz. You may re-review the modules and repeat any quizzes to attain the overall passing score of 80%. (Once you have completed all of the required modules in your curriculum you will be shown optional modules which may be completed at a future time. 
6. Upon successful completion of the modules and associated quizzes, save a copy of your completion report for your records.

For Technical Support: 
Contact eBridge Help Desk

Go to CITI Website

Social/Behavioral Research (SBR) encompasses a wide variety of research including but not limited to:

• Observational,
• Survey research,
• Epidemiological studies

This research does not involve any drugs or devices (investigational or market-approved). This course is listed as Social/Behavioral Learner Group.

Course instructions: 

1. Go to citiprogram.org or click the link below.
2. Enter username and password used to register with the CITI Program.
3. On the Main Menu Page, click on Social/Behavioral Learner Group to begin. 
4. Complete the Integrity Assurance Statement. 
5. Complete the required modules and associated quizzes and one elective module and quiz. You may re-review the modules and repeat any quizzes to attain the overall passing score of 80%. (Once you have completed all of the required modules in your curriculum you will be shown optional modules which may be completed at a future time. 
6. Upon successful completion of the modules and associated quizzes, save a copy of your completion report for your records.

For Technical Support: 
Contact eBridge Help Desk

Go to CITI Website

1. Go to citiprogram.org
2. Click on the "Register" button located on the right-hand side of the page.
3. Enter "Medical College of Wisconsin" as your organization and click on "Continue"
4. Enter your first and last name and email address and click on "Continue". (Recommendation - list your first and last name and email address as listed in your eBridge account and consider including a secondary email address)
5. Choose a username and password for your CITI account following the instructions for each field; you must also select and answer a security question and click on "Continue".
6. Provide information regarding gender, ethnicity and race and click on "Continue".
7. Provide information regarding CE credits and completion of surveys and click on "Continue". CE credits are available for purchasing by the individual.
8. Provide the required information for the Medical College of Wisconsin as identified by the *.
9. Select the CITI course that most closely matches your research and your role in research; choose from Biomedical Learner Group, Biomedical Research and Good Clinical Practices, Social Behavioral Learner Group or Group 6: Healthier Wisconsin Partnerships Community Members and click on "Next".

1. Go to citiprogram.org.
2. Enter username and password used to register with CITI Program.
3. On the Main Menu page, click on the course title to begin or continue the coursework.
4. Complete the Integrity Assurance Statement.
5. Complete the required modules and associated quizzes and one elective module and quiz. You may re-review the modules and repeat any quizzes to attain the overall passing score of 80%. (Once you have completed all of the required modules in your curriculum you will be shown optional modules which may be completed at a future time).
6. Upon successful completion of the modules and associated quizzes print a copy of your completion report for your records.

The total time is approximately 4 to 6 hours for the basic course and less than 2 hours for the refresher course.

You may complete it multiple sittings.

The certification program is web-based and can be accessed online from anywhere.

If you have forgotten your user name and/or password, click on “Forgot username or password?” link on the CITI Program homepage and follow instructions.

1. Go to citiprogram.org.
2. Enter username & password.
3. Click on "My Profiles" then click on the applicable link ("Change my name", "Change my email address").
4. Enter the updated information click on "Update".

• The recorded first and last name in the CITI Program and eBridge accounts are not the identical. To correct this, update your CITI Program account information to reflect your name as documented in eBridge; see "How do I update my name/email address?" for further instruction.
• The email address listed in eBridge differs from the preferred email address listed with CITI Program. To correct this, update your CITI Program account information to reflect your email address as documented in eBridge; see "How do I update my name/email address?" for further instruction.
• There is more than one CITI Program account associated with an individual's name. To correct this please contact HSRPtraining@mcw.edu and request that your accounts be merged.
• You have not completed the affiliation of CITI Program training with the Medical College of Wisconsin. To correct this, please complete the process as described in "How do I add MCW/change my affiliated institution or transfer my completions?".

1. Go to citiprogram.org
2. Enter username & password
3. On the Main Menu page your current Learner Group is listed under Course. To change your learner group click on “Add a Course" located in the section "My Learner Tools for Medical College of Wisconsin".
4. Select the Learner Group that most closely matches your role and type of research (Biomedical Learner Group, Biomedical Research and Good clinical Practices, Social Behavioral Learner Group) and click on "Next".
5. Indicate whether you will be completing the initial course or refresher course for that Learner Group and click on "Submit".
6. On the Main Menu page Under “Course” you should see a the status for the course (Not Started or Incomplete)
7. Click on the Course link and begin course work for modules which still require to be completed for the new Learner Group which was selected.
8. On the Main Menu page in the section "My Learner Tools for Medical College of Wisconsin" click "View Previously Completed Coursework" and verify previous CITI completed modules are displayed.

• If you are involved in human subject research at either Children’s Wisconsin, or the Clement J. Zablocki VA Medical Center and are current in your human subject protection training, MCW will accept this training.
• If you have completed human subject protection training at an institution other than Children’s Wisconsin or the Zablocki VA and request MCW acceptance of the training, please contact HSRPtraining@mcw.edu.
• For projects where MCW is serving as the IRB of Record for another institution outside of MCW, FH or BCW, the MCW HRPP office may accept human subject research protections training from another institution provided either of the following conditions are met:
  • The institution has current AAHRPP accreditation, or
  • The institution is a part of a CTSA-awarded consortium

1. Go to citiprogram.org.
2. Enter username & password used to register with CITI at previous or other institution.
3. On the Main Menu page, click on "My Profiles" to edit or change your email address as needed.
4. On the Main Menu page, click on the link “Affiliate with Another Institution”. Enter "Medical College of Wisconsin" (MCW) as your organization and click on "Next".
5. Provide the requested information for MCW's registration questions.
6. Enroll in the course - human subject research and select the Learner Group that most closely matches your role and type of research; Biomedical Learner Group, Biomedical research and Good clinical Practices or Social Behavioral Learner Group.
7. On the Main Menu page in the section "My Learner Tools for Medical College of Wisconsin" Click "View Previously Completed Coursework" and verify previous CITI completed modules are displayed. (To receive credit for modules previously completed you must be affiliated with both institutions; enroll in the course that needs to be transferred via "Add a Course" link for MCW and select the applicable Learner Group. Once you are enrolled in the course, any modules that are shared between the institutions will have their credit transferred automatically. The transfer is based upon the module's unique ID number. Each institution determines the timeframe in which modules are transferable, some institutions do not allow modules to transfer. )
8. On the Main Menu page you will see the selected Learner Group for MCW and status of "Not Started" or "Incomplete".
9. Click on the Learner Group to see the list of the required modules for MCW; complete the incomplete modules and associated quizzes. In addition to completing the required modules you must also complete one elective module and quiz.

Please note: Institutions choose from a wide variety of modules and overlap with MCW modules will vary. All modules required for MCW certification must be completed.

1. Go to citiprogram.org.
2. Enter username & password.
3. Click on "Remove Affiliation" found in the section "My Learner Tools for Medical College of Wisconsin".

Removing your affiliation will also remove access to completion report records for this institution