Faculty, employees, students and other institutional representatives at UNMC/Nebraska Medicine/CH&MC and UNO are required to complete the Human Subjects Research (HSR) Course via the Collaborative Institutional Training Initiative (CITI) website if they will be working on a research project that involves human subjects. The course is presented as several modules with a brief quiz at the end of each module to assess understanding of the material. A cumulative passing score of 75% is required for successful completion and is valid for a period of 3 years at which time a refresher course must be taken. It takes approximately 2-3 hours to complete the Basic course. However, the training does not have to be completed in one sitting but can be spread out over time if needed.
The Good Clinical Practice (ICH focus) modules are now required for all individuals involved in the conduct of clinical trials involving drugs and/or devices. This GCP course meets the minimum criteria for training identified by some sponsors. (Check to see if your sponsor is listed.) If so, your CITI completion report can be supplied to the sponsor to meet their GCP training requirement.
UNMC/Nebraska Medicine/CH&MC - Instructions
All individuals at UNMC/Nebraska Medicine and/or CH&MC involved in the conduct (i.e., listed on the IRB application) must complete either Group 1 or Group 2. The group assignment is explained below:
- Group 1: If none of the IRB application(s) that you are or may be listed on (in the foreseeable future) are considered a clinical trial involving drugs or devices, you must complete Group 1.
- Group 2 GCP: If any of the IRB application(s) that you are or may be listed on (in the foreseeable future) are considered a clinical trial involving a drug or device, you must complete Group 2 and Group 1.
UNO - Instructions
Most individuals at UNO involved in the conduct (i.e., listed on the IRB application) will complete Group 3. Those involved in the exercise science programs (i.e., HPER) will complete Group 1.
BASIC OR REFRESHER?
All individuals must complete the BASIC HSR course before the REFRESHER HSR course. If you did not complete the BASIC course through UNMC/UNO, you will be required to email a copy of your Completion Report to the IRB Office. You can access your Completion Report by logging into the CITI website using your previous username and password. If you need assistance with your username and password from an institution other than UNMC/UNO, you can contact CITI Support at (305) 243-7970, Option #1. It is highly recommended that you email the Completion Report prior to beginning the REFRESHER course.
For all questions regarding CITI training, please the IRB Office at (402) 559-6463 or email.