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CITI Instructions for Human Subjects Training at UConn Health

Introduction

All  personnel involved with the conduct of human subject research (inclusive of those key personnel listed on an IRB application or request for modification) must complete training in the protection of human subjects.  Courses offered through the Collaborative IRB Training Initiative (CITI) are the primary mechanism used to satisfy this requirement.  Once passed, the training is valid for a three year period.  Training is required to be current at the time of initial approval or at the time the individual is added to a study.

Completion of CITI courses is strongly encouraged for anyone providing support to a study who is not designated as key personnel on the IRB application or modification form.

Instructions for registering for CITI courses are provided below. When registering for Human Subjects Training do not register to  take the animal modules.

Individuals may check their training completion date in IRIS or in their CITI account.

CITI Registration

Go to https://www.citiprogram.org.

  • If you are a new user click Register in the upper right corner, or from within the Create an account box on the right side of the screen.
  • If you are a returning user, Click Log In in the upper right corner, or type in your user name and password on the right side of the screen and click Log In

Please note that steps 1 – 6 area applicable to new registration. Returning users should skip to Step 7 regarding course enrollment

Step 1:  Select Your Organization Affiliation:

  • In the box to “Search for organization” type University of Connecticut Health Center, selecting this option when it becomes available. (Note: Be sure to include Health Center in your selection)
  • Click Continue to Step 2

Step 2:  Personal Information:

  • Provide responses to the required fields denoted with an *
  • Provide secondary email if you choose.
  • Click Continue to Step 3

Step 3:  Create your own User Name and Password

  • Create your username in accordance with noted requirements
  • Create your password in accordance with noted requirements
  • Select a security question
  • Provide a security answer
  • Click Continue to Step 4

Step 4:  Gender, Race, Ethnicity

  • Provide responses to required fields (with an *)
  • Click Continue to Step 5

Step 5:  Continuing Education Credits

  • Provide responses to required fields (with an *)
  • Click Continue to step 6

Please note that it is not necessary to say YES to CEs to obtain a certificate of completion

Step 6:  Additional Details (Note: per CITI this step cannot be skipped, but responses are not required. )

  • Provide responses (optional)
  • Click Continue to step 7

Step 7:  Course Enrollment Procedure:

  • Read the instructions below for details.
  • For returning users, once logged into CITI, click University of Connecticut Health Center to see any assigned courses. Click on the course to begin it, responding to the integrity assurance statement if required. If necessary (i.e. you are up for renewal, but a course had not yet been assigned), click Add a Course under University of Connecticut Health Center and then follow the instructions below.

Course Enrollment Questions:  

On the CITI site, scroll down to the section with questions.

User can skip questions in this process unless the question is denoted with an * which indicates a response is required.   New users should first select the user group most applicable to the type of research with which the user will be involved.  If a user only wants to take a Good Clinical Practice (GCP) training module, skip to question 3 to register for a GCP course for the first time, or to question 4 to renew GCP training.

The questions you will see on the CITI course enrollment page are provided below for reference, along with instructions for responding.

Question 1 – Human Subject Research Instructions:

Select the ONE option that best reflects your status. Only select the last option if you have previously completed CITI training at UConn Health and are now renewing your training because the three year expiration date is approaching. (Note: IRB chairs should select Group 4 initially. Group 5 can be added after the initial registration and course is completed.  IRB members and HSPP staff must initially select Group 4)

Question 1:  Please choose one learner group below based on your role and the type of human subjects activities you will conduct. You will be enrolled in the Basic Course for that group.

  • Group 1: Biomedical Investigators and Study Personnel
  • Group 2: Social and Behavioral Investigators and Study Personnel
  • Group 3: Students
  • Group 4: IRB Members or HSPP / IRB Staff
  • Group 5: IRB Chair
  • I have completed the Basic Course.

Question 2 – Refresher Courses Instructions:

For users who are renewing training, select the one option that best reflects your status, or for an alternative refresher course option, skip question 2 and select the Good Clinical Practice course in Question 3 to satisfy refresher requirements.

  • If in question 1 you indicated that you have completed the Basic Course, then select option 1, 2, 3 or 4 in question 2, or skip question 2 and select the alternative option of completing the Good Clinical Practice course in option 3.
  • If in question 1 you selected a Group designation, then respond to question 2 by selecting “I have not completed the Basic Course.”

Question 2:  If you have completed the Basic Course portion, please choose one learner group below based on your role and the type of human subjects activities you will conduct.  You will be enrolled in the Refresher Course for that group.

  • Group 1: Biomedical Investigators and Study Personnel
  • Group 2: Social and Behavioral Investigators and Study Personnel
  • Group 3: Students
  • Group 4: IRB Members or HSPP / IRB Staff
  • I have not completed the Basic Course.

Question 3 – Good Clinical Practice Instructions: 

Individuals involved with NIH funded clinical trials  must also complete GCP training, in addition to human subjects training.  UConn Health strongly encourages all other individuals who are involved with clinical research trials to take the GCP course.  Individuals involved with FDA-regulated research should take this training.  Individuals can opt to select the GCP course in addition to any other course selection in items 1 and 2, or to skip the GCP course (unless otherwise mandated by the NIH or IRB).

Question 3:  If you are required to take: Good Clinical Practice (GCP) then please make your selection below.

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) – For clinical trials in the US
  • GCP for Clinical Investigations of Devices
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) – For international clinical trials
  • GCP – Social and Behavioral Research Best Practices for Clinical Research
  • Not at this time.

Question 4 – Good Clinical Practice Refresher Instructions: 

If you are renewing GCP training select from the applicable course

Question 4:  Please make your selection below if you have previously completed the GCP Basic Course.

  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) – Refresher – For international trials
  • GCP for Clinical Investigations of Devices – Refresher
  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) – Refresher – For clinical trial in US
  • I have not completed the Basic Course

Question 5 – Question 7 may be skipped when registering for only human subjects training courses.  If a user is required to take the course by another area of UConn Health, the course may be selected here.

After completing the course enrollment questions click Submit

To access the course for which you have registered

  • Click University of Connecticut Health Center Courses
  • Click on the assigned course to begin the work
  • Click to complete the Integrity Assurance Statement before beginning the course
  • Click on Required Modules to complete them in order.

To Successfully Complete the Course

A running tally is compiled in the Grade Book to ensure that the minimum passing score has been met.   If you want to improve a score on a quiz, you may repeat any quiz in which you didn’t score 100% correct.

Print or download a Course Completion Report as evidence that you have met your institutional requirements.  A copy will be sent to your institutional administrator.  Certificates may also be downloaded at a later date by following these instructions.

Questions

  • Questions regarding your requirements for human subjects training should be sent to irb@uchc.edu