Required Education

Collaborative Investigator Training Initiative (CITI) – Required human subjects protection education

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Basic CITI – Required for new investigators, research staff, and those new to VCU

What is CITI?  VCU requires investigators and key personnel to complete the Collaborative IRB Training Initiative (CITI) Basic Course in either Biomedical or Social-Behavioral Research as baseline entry into human subjects research at VCU. The course and exam are web-based and can be accessed at www.citiprogram.org.  All the modules listed for VCU must be completed.  There is a short quiz after most modules.  An aggregate passing score of 80% is required.  New protocols (including ‘exempt’), continuing reviews, and change to research submissions will be forwarded for IRB review only after the principal investigator’s completion of the required CITI Biomedical or Social-Behavioral Course has been verified. The CITI Refresher course does not qualify as a Basic course. Make sure you take the Basic course if you have not yet done so at VCU or another institution.

Who takes CITI? All key study personnel, including the principal investigator, sub-investigators, study coordinators, and students, are required to complete the Basic CITI human subjects protection education in either Biomedical or Social-Behavioral Research.  Key personnel are persons involved with the research protocol through interacting or intervening with research participants or their identifiable data. Those obtaining informed consent from a study participant, or having access to identifiable data, are considered key personnel. Upon request by the investigator, the IRB may consider alternate training arrangements for certain kinds of research involving key personnel.  IRB members and staff are expected to take both Basic Courses. 

 
How long does it take and when does it expire?  Depending on your experience with human subjects research, the Basic CITI course can take 4 to 6 hours to complete.  It does not have to be completed in one sitting.  Verification of completion is sent to you immediately.  Print off a copy and retain in your files.  The Basic course expires 2 years after completion, at the end of the year.  CITI generates a reminder email 30 days before the Basic course expires.  The Basic CITI course must be completed before qualifying for the Refresher course. CME’s and CEU’s are available for CITI completion.  See the CITI site for more information.

 
Registration for CITI   CITI can be accessed at www.citiprogram.org.  Closely follow the directions for first time registration.  Write down your user name and password and save it.   Use this same username/password for all subsequent entry into CITI.  Indicate your affiliation with Virginia Commonwealth University in order for VCU to obtain your record.  When completing the Registration Profile as a first-time CITI participant, DO NOT indicate prior completion of another human subjects protection course.  To take the Basic Course, choose a Learner Group that is appropriate to your activities in human research.  The program will automatically select the modules you are required to complete. Follow the instructions and links on the Learner’s Menu to begin the Basic course. Use the “View/Update your Learner Group” link on the Learner’s Menu to select or change groups for the Basic Course.  Retain the username and password used to create the CITI account and complete the Basic course.   DO NOT take the Refresher course if you have not previously taken the Basic course at VCU or another institution.  

Transferring your Basic CITI record to VCU   Depending on how much time has elapsed, a Basic CITI course taken at another institution can be electronically transferred to VCU.  To do so, click on the ‘Affiliate with Another Institution’ account link. Choose Virginia Commonwealth University. You will need to review the VCU module, plus complete any modules that your former institution did not require.  Once you have completed all VCU modules, your completion will show up in the CITI VCU database. In most cases, VCU will honor the completion certificate from another institution.

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Refresher CITI - required for investigators, research staff, and students who have taken Basic CITI

Who takes the CITI Refresher course? All key study personnel, including the principal investigator, sub-investigators, study coordinators, and students, are required to complete the Refresher CITI human subjects protection education in either Biomedical or Social-Behavioral Research after their Basic expires.  IRB members and staff are expected to take the Refresher course that is relevant to their IRB Panel (or their research, if investigators) as well as the IRB Learner Group Refresher course.   Use the same username and password for the Refresher course as was used for the Basic course.

When is the Refresher course required?  All Basic and Refresher Biomedical or Social-Behavioral courses completed prior to and including 2007 will require Refresher course completion for submission to the IRB.  The Refresher Course will expire 2 years after completion, at the end of the year.   CITI generates a reminder email 30 days before the Refresher course is due. 

To find out when you took the Basic or Refresher CITI, check a printed copy of the completion certificate or go to the CITI website. Enter the user name and password that was used to complete the Basic or Refresher course.  On the Learner’s Menu scroll down to ‘Previous Coursework Completed’ and click.  Go to “Coursework completed.’  Check your  course completion status. If the date under ‘Course Completed’ is  during the year 2007 your  course will expire on Dec. 31, 2009.  If the completion date is prior to 2007, your CITI course has already expired. (Note that the printed expiration date is not applicable).  If you do not know your username and password, either contact CITI directly using the “Forgot username or password” retrieval tool on CITI’s home page (www.citiprogram.org) OR you may contact Ms. Zena Bailey in the Office of Education and Compliance Oversight.  Requests through CITI or Ms. Bailey are on a first-come, first-served basis, and may take a week or more to process; please plan accordingly.  Ms. Bailey may be contacted at zbailey@vcu.edu. 

How long does the Refresher course take and when does it expire?  The Refresher course takes about 2 hours to complete.   It does not have to be completed in one sitting.  Verification of completion is sent to you immediately.  Print off a copy and retain in your files.  CITI generates a reminder email 30 days before the Basic or Refresher course expires.  The Basic CITI course must be completed at VCU or another institution before qualifying for the Refresher course.   Use the same username and password for the Refresher as was used for the Basic course. 

During transition to the Refresher course, all Basic courses taken during or prior to the year 2007 will expire at the end of 2009.  Basic courses completed after 2007 will expire 2 years after completion, at the end of the year.  See chart below for examples.

Note:  The Refresher course will expire 2 years after it is completed, at the end of the year.  In some cases, a sponsor will require an earlier completion.  Using the same username and password, enter CITI and take the Refresher course at any time.  The completion dates will be updated.

How do I know which modules are required for the Refresher course?
When you enter CITI using the username and password used for the Basic course, you will be automatically routed to the Refresher course.  Take the Refresher course in the Learner Group most relevant to your research activities – Biomedical or Social-Behavioral Research.  Note that you can change your learner group.  A total number of 12 modules are to be completed for each learner group.  Depending on the learner group, some modules are required for everyone.  In addition, you can choose from a selection of elective modules to total 12.  Refresher course completion requires taking a total of 12 modules.  The required total number for the Refresher course must be completed before any optional courses are available. CME’s and CEU’s are available for CITI completion.  See the CITI site for more information. 

Transferring your Refresher CITI record to VCU   Depending on how much time has elapsed, a Refresher CITI course taken at another institution can be electronically transferred to VCU.  To do so, click on the ‘Affiliate with Another Institution’ link. Choose Virginia Commonwealth University. You will need to review the VCU module, plus complete any that your former institution did not require.  Once you have completed all VCU modules, your completion will show up in the CITI VCU database. In many cases, VCU will honor the Refresher completion certificate from another institution.   

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More questions and answers
I completed the CITI Basic course in either October of 2006 or 2007, when does it expire?
If the Basic course was completed in 2006, the Refresher course was due by January 1, 2009.  If the Basic course was completed in 2007, itwill expire on December 31, 2009.  You will need to take the CITI Refresher course by January 1, 2010 to keep your human research protections training current.  Use the same username and password for the Refresher as was used for the Basic course.

I completed the CITI Basic course February 14, 2007, when does it expire?
Your CITI Basic course will expire on December 31, 2009.  You will need to take the Refresher course by January 1, 2010 to keep your human research protections training current.

I completed the CITI Basic course April 26, 2008, when does it expire? 
Your CITI Basic course is current at this time.  It will expire on December 31, 2010.  You will need to take the Refresher course by January 1, 2011 to keep your human research protections training current.

How do I find out if I am due for the Refresher course and how do I log on? 
To find out when you took the Basic CITI, check a printed copy of the completion certificate or go to the CITI website. Enter the user name and password that was used to complete the Basic course.  On the Learner’s Menu scroll down to ‘Previous Coursework Completed’ and click.  Go to “Coursework completed.’  Check your Basic course completion. If the date under ‘Course Completed’ is within the year 2007, your Basic course expires on Dec. 31, 2008.  (Note that the printed expiration date is not applicable).  If you do not know your username and password, either contact CITI directly using the “Forgot username or password” retrieval tool on CITI’s home page (www.citiprogram.org) OR you may contact Ms. Zena Bailey in the Office of Education and Compliance Oversight.  Requests through CITI or Ms. Bailey are on a first-come, first-served basis, and may take a week or more to process; please plan accordingly.  Ms. Bailey may be contacted at zbailey@vcu.edu. 

What happens if my Basic CITI course expires and I have not taken the Refresher course?   
New protocols (including ‘exempt’), continuing reviews, and change to research submissions will be forwarded for IRB review after the principal investigator’s completion of the CITI Biomedical or Social-Behavioral Refresher Course has been verified.  Investigators and key personnel must have taken the Basic course before qualifying for the Refresher course.

Is the Good Clinical Practice course required for those conducting Biomedical Research? 
The Good Clinical Practice (GCP) Course through CITI is not required at this time.  It is an optional course available to VCU research teams.  The GCP does not qualify as a Basic or Refresher course; it is an educational option.

How do you take the Optional Modules listed under the Learner Groups?
The optional modules become available after the required number of modules are completed.

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For questions about VCU CITI requirements contact Ms. Zena Bailey, Office of Education and Compliance Oversight, at zbailey@vcu.edu or 827-2156.  Note that your questions will be addressed on a first come, first served basis.