CITI Courses

USC CITI Help Desk
(213) 821-5272
citi@usc.edu

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TRAINING

Instructions for CITI and ISTAR

About CITI

CITI (Collaborative IRB Training Initiative) was founded as a collaboration between the University of Miami and Fred Hutchinson Cancer Research Center to develop a web based training program in human subjects protection. Consult the information below before visiting www.citiprogram.org.

CITI Courses

 

COURSE REQUIREMENT DESCRIPTION
Human Subjects Protections “Basic Course” for Health Science Campus (HSC) Complete if you are conducting biomedical research with human subjects.
Investigators, Key Personnel and IRB Members/Staff must complete any 8 of 17 available modules with a passing score of 80%.
Refresher training must be taken every 3 years.
Learning objectives: ethics and principles, laws and regulations, informed consent, vulnerable populations, and more.
Human Subjects Protections “Basic Course” for University Park Campus (UPC) Complete if you are conducting social-behavioral research with human subjects.
Students, faculty advisers, and those conducting Exempt Research must complete 4 modules with a passing score of 80%.
Faculty/Staff Investigators, Key Personnel and UPIRB Members/Staff must complete any 8 modules with a passing score of 80%.
Refresher training must be repeated every 3 years.
Learning objectives: ethics and principles, laws and regulations, informed consent, vulnerable populations, and more.
Good Clinical Practice (GCP) Good Clinical Practice (GCP) training is required for  USC PIs and personnel conducting Expedited and Full Board clinical trials. Training is intended for study staff who have interaction, conduct intervention, or have access to subject identifiable information. A study will NOT be approved until the training requirement is met. All 15 modules must be completed with a passing score of 80%.
No refresher course is necessary.
Learning objectives: international ethical and scientific standard expected in design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
Responsible Conduct of Research (RCR) All investigators on NSF grants, as well as some NIH training awards, and PHS traineeships must complete 9 modules with a passing score of 80%.
No refresher course is necessary.
Cannot be substituted for Human Subjects Protections training.
Learning objectives: ethics, data integrity, collaborative research, and more.The USC Office of Compliance will provide the certificate of completion.
Conflict of Interest All USC Investigators supported by HHS funding must complete 3 modules with a passing score of 80%.
Refresher training must be repeated every 4 years.
For more information visit the USC Conflict of Interest page.
Generic Classroom Mandated at the discretion of the instructor, this course is sometimes used as an assignment for research methods courses.
Must complete 4 modules; two modules from the Human Subjects Protections course and two from the Responsible Conduct of Research course.
Learning objectives: ethics and principles, laws and regulations, informed consent, vulnerable populations, and more.

 

HIPAA 

NOTE: the USC HIPAA course is not hosted by CITI

HIPAA training is required for all investigators who have access to Protected Health Information such as patient health records.
Visit the USC Office of Compliance website to access the HIPAA course.
ooc.usc.edu/hipaa-privacy-education-program

“Key Personnel”

Key personnel are any individuals responsible for the protocol development or design, conduct, or reporting of research. These include but are not limited to: Principal Investigators (PIs), Co-PIs, faculty advisors, study coordinators, recruitment staff, and anyone else performing study procedures or interventions.

Accessing CITI

Please refer to the Instructions for CITI and ISTAR manual for course registration, completion instructions, and printing your certificate. In addition, CITI and iStar are separate systems: while you can use the same log-in information for both you will need to register for each separately.

Previously Completed/Expiring Human Subjects Certificates

I already have certification from an outside institution…

Human subjects certifications completed within the past 3 years may be accepted at USC’s discretion, but a copy must first be emailed to citi@usc.edu make that determination.

I received a notice from iStar indicating my certificate is about to expire, what do I do?

If you received a notice from iStar indicating your certificate is about to expire, you must re-certify. The human subjects education policy is that investigators/key personnel must complete training every 3 years. Please refer to “Signing Up For A Refresher Course” in the Instructions for CITI and ISTAR manual.

I need to complete GCP training and the human subjects “refresher” course, must I take both?

No. Investigators/key personnel that complete GCP training DON’T need to complete the human subjects “refresher course” (course offered in CITI after initial three year certificate expires). The GCP course will fulfill the “refresher” human subjects training requirement for three years from the date it is completed. However, the human subjects “refresher course” does not fulfill the GCP training requirement. GCP training is a one time requirement while human subjects education is required every three years.

Human Subjects Training

Do I need to take Human Subjects Protections Training if a project is “exempt”?

Yes, even if a project is exempt, study personnel are still required to take Human Subjects Protections Training.

If a project was determined to be “not human subjects research”, do I need to take Human Subjects Protections Training?

No. If a project was determined to be “not human subjects research” (NHSR) (e.g., this applies whether coded specimen/data or not meeting the federal definition) study personnel do not need to take the Human Subjects training on CITI.

If I already completed HIPAA Training, do I need to take Human Subjects Protections Training?

Yes, you must complete Human Subjects Protections Training even if you completed HIPAA Training.

Do I need to take Human Subjects Protections Training for amendments to a previously approved IRB application?

Amendments for adding “key personnel” on a study require that the added individual(s) complete CITI before the amendment is approved.

 

Questions or Comments

USC CITI Help Desk
(213)-821-5272
citi@usc.edu