Human Subjects Protection Training Requirements
Investigators and research staff who interact or intervene with human research subjects, or who use subjects’ identifiable information for the purposes of research, must complete Colorado State University’s required Human Subjects Research Training Courses relevant to the type of research being conducted and the investigator or staff member’s responsibilities.
CSU utilizes the CITI program to facilitate Human Subjects Research Training. Once complete, course certification is valid for 3 years. Refreshers are required every 3 years following completion of the main course.
Based on their roles, researchers should choose to complete one of the following courses:
- Group 1: Biomedical Research
- Group 2: Social Behavioral Research
You do not need to complete the entire Course in one session. Re-enter as often as you like, using your username and password, to complete the training.
You must complete all required modules with a cumulative score of 80% or better to pass the course.
Evidence of current training (date of completion within 3 years of application date) for each member of the research team is required with every new study application and applications to add study personnel. New study applications and additions of study personnel will not be moved forward for IRB review without evidence of training.
CITI Tips for first-time access:
- Click “Register” and affiliate yourself with Colorado State University
- Enter your name/email address and secondary email address
- Create username/password, add security question
- Select the training track that you wish to complete
GCP training is required for clinical investigators and clinical staff who are involved in the design, conduct, oversight, or management of clinical trials. If your clinical trial is NIH-funded or under the regulations of the FDA, Good Clinical Practice (GCP) is required to be refreshed every 3 years. By taking this CITI Program course, you meet both standards. The re-fresher course will be auto-assigned prior to the expiration of your original training. If you need additional guidance feel free to contact either: email@example.com (manager, clinical research affairs) or CSU_IRB@colostate.edu
**Effective January 1, 2017 – NIH expects all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP). Recipients of GCP training are expected to retain documentation of their training. GCP training should be refreshed at least every three years in order to stay up to date with regulations, standards, and guidelines.
If a protocol is NIH funded, all key personnel (as defined by NIH) must complete the training.