MCW Human Research Protections Training - CITI 

 

To Login/Access CITI online program: https://www.citiprogram.org
 

Introduction 

Welcome to the MCW Human Research Protections training via Collaborative IRB Training Initiative (CITI).  

In 2004 MCW announced the requirement to all individuals involved in the design, conduct or review of human subjects research to have been certified under a new educational program. 2004 Certification Letter

The program requirements include reading the Belmont Report and key MCW research documents and policies, completing the required learner groupof the Collaborative IRB Training Initiative (CITI) Program, and maintaining CITI certification while engaged in the conduct of human subject research.  

The CITI Program website content is offered in English, French, Japanese, Korean, Portuguese, Russian, and in Spanish.  The Medical College of Wisconsin has created Learner Groups 9 and 10 for Spanish Language Biomedical researchers and Spanish Language Social and Behavioral researchers.

CITI Basic 

Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW/FH IRBs or another authorized IRB must obtain CITI certification.  CITI certification is obtained by completing the required online modules 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.

New employees must complete the required modules and obtain CITI certification within prior to .
Members of the human subject research team, including the Principal Investigator (PI), must have current certification. 

CITI Refresher 
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. 

The required learner group depends on the type of research you may be conducting or engaged in and the descriptions are noted below. 

 

Learner Groups and Types of Research

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  Biomedical Research (formerly Learner Group 1 & Learner Group 2)
  • Biomedical involves all types of clinical research studies, including FDA-regulated research and those that involve investigational drugs, biologics, and devices.
    1. Investigational devices encompass a wide variety of items. The following are examples which would be considered investigational devices:
      1. Non-FDA cleared devices (both implantable or one which will be applied to just the surface of the body)
      2. investigational software packages which will be run on a FDA cleared device (such as WIP MR pulse sequences, or post-processing analysis software);
      3.  in-vitro diagnostic assays (IVD), laboratory developed tests (LDTs);
      4. Certain types of mobile applications which will provide a clinical decision (without physician or provider input)
  Biomedical + GCP Learner Group 11

This learner group combines both Biomedical learner group 1 along with the optional Good Clinical Practices (GCP) learner group. 

 

Learner Group 11 allows Investigators to seamlessly complete both learner groups and will ensure that these trainings and certifications are renewed every 3 years. Completion of this learner group will assist Investigators and research study staff in complying with Sponsor, or MCW departmental/division research requirements. 

 

  Social/Behavior Research (formerly Learner Group 4 & Learner Group 5)
  • Social/Behavioral Research (SBR) encompasses a wide variety of research including but not limited to: observational, or survey research, work with population and/or epidemiological studies.
    • This research does not involve any drugs or devices (investigational or market-approved)
  Community Engagement or Community Based Participatory Research (CBPR),Community Partners - Learner Group 6

The Advancing a Healthier Wisconsin Endowment, stewarded by the Medical College of Wisconsin, has a mission to work with partners to serve as a catalyst for positive change in the health of Wisconsin communities.

This learner group has been designed to focus on the unique aspects to consider and be aware in the conduct of human subject research based in the community.  This learner group is made available as the HSR training for community partners* participating in the conduct of human subject research.

*Completion of this learner group will not fulfill the HSR training requirements for MCW/FH IRB for MCW/FH faculty, staff or students engaged in the conduct of human subjects research. 

Frequently Asked Questions

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  What do I do if I forgot my user name or password?

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.  

  How do I register, create my CITI Program account, and select my Learning Group Modules?
  1. Go to www.citiprogram.org and click on the "Register" button located on the right-hand side of the page.
  2. Step 1: enter "Medical College of Wisconsin" as your organization and click on "Continue"
  3. Step 2: 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)
  4. Step 3: 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".
  5. Step 4: Provide information regarding gender, ethnicity and race and click on "Continue".
  6. Step 5: Provide information regarding CE credits and completion of surveys and click on "Continue".  CE credits are available for purchasing by the individual.
  7. Step 6: Provide the required information for the Medical College of Wisconsin as identified by the *.
  8. Select the Learner Group that most closely matches your research and your role in research; choose from Learner Groups 1-6, or 8 and click on "Next".
  How do I access/complete the CITI modules?
  1. Go to www.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.  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.
  How do I add MCW/change my affiliated institution or transfer my completions?
  1. Go to www.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 (Group 1 – 6 or 8)
  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 or Update Learner Groups' 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. 

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.

  How do I remove my affiliation from an institution?
  1. Go to www.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

  How do I update my name and/or email address?
  1. Go to www.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".
  How do I change learner groups on CITI?
  1. Go to www.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 or Update Learner Groups" 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 (Group 1 – 6, or 8) 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.
  Will my training that I completed at another institution be accepted?

If you are involved in human subject research at either Children’s Hospital of Wisconsin, or the Zablocki Veterans Administration 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 Hospital of Wisconsin or the Zablocki Veterans Administration Medical Center and request MCW acceptance of the training, please contact HSRPtraining@mcw.edu 

  How long will it take to complete the certification program?

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 from any computer via the internet.

  Why can I not see information regarding my completed CITI Program Modules in eBridge?
  1. 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.
  2. 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.
  3. 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.
  4. 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?".

Contact

Whom should I contact if I have questions about logging on, updating institution or learner information, or I am visually impaired?
Please contact HSRPtraining@mcw.edu

Medical College of Wisconsin
8701 Watertown Plank Road
Milwaukee, WI 53226
(414) 955-8296
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Page Updated 05/13/2016
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