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CITI Instructions for Human Subjects Training at UConn Health

Introduction

All personnel involved with the conduct of human subject research must complete training in the protection of human subjects. CITI courses are used to satisfy this requirement.  Once passed, the training is valid for three years after which time training must be renewed.  Instructions for both the initial and refresher 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 on the master training list (Excel) which is updated approximately every two weeks. Completion of required training will be verified by the IRB Office prior to IRB approval being granted. Training is required regardless of the type of review being requested.

CITI Sign On

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 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 * (First Name, Last Name, Email Address, Verify email address)
  • 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 (Gender, Ethnicity, Race)
  • Click Continue to Step 5

Step 5:  Continuing Education Credits

  • Provide responses to required fields
  • Click Continue to step 6

*NOTE: It is not necessary to say YES to CE’s to obtain a certificate of completion

Step 6:  Additional Details (Note: per CITI this step cannot be deleted, but responses are now optional. )

  • 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.

NOTE:  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 and take the applicable course.  If a user only wants to take a 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 ICH focused course is for international clinical trials.  The FDA focused course is for US Clinical trials.   Users may also elect to take the GCP course in addition to the courses assigned to a particular user group.

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

Question 1 –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. RB members and HSPO staff must complete 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 HSPO / IRB Staff
  • Group 5: IRB Chair
  • I have completed the Basic Course.

Question 2 – 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 HSPO / IRB Staff
  • I have not completed the Basic Course.

Question 3 – Instructions: 

The HSPO/IRB strongly encourages individuals who are involved with clinical research trials to take this course to satisfy, but does not mandate it.  However, individuals involved with NIH funded clinical trials  must complete GCP Training.  Individuals can opt to select the Good Clinical Practice Course in addition to any other course selection in items 1 and 2, or to skip the Good Clinical Practice Module (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
  • Not at this time.

Question 4 – 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. 

 

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 being 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

The minimum “passing” aggregate score for the quizzes is 80%. A running tally is compiled in the Grade Book.   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.

Questions

  • Questions regarding your requirements for human subjects training should be sent to