Completion of the basic (initial) Collaborative Institutional Training Initiative (CITI) course (either Biomedical or Social/Behavioral) is required for all Georgia Tech investigators who will conduct human subjects research, regardless of funding status. CITI training must be refreshed every three years by completing the refresher modules.
Step-by-Step Instructions for Completing CITI Human Subject Basic Course
Training certifications will be manually entered into individuals' profiles in IRBWISE by ORIA staff. Do not delay submitting a protocol or amendment while waiting for training certification to appear. Certifications will only be entered after submission of a protocol or amendment that names the individual.
If your human subjects research involves the Department of Defense, you may need to complete the Department of the Navy CITI modules, which satisfies Georgia Tech's CITI training requirements.
Good Clinical Practice Training
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.
The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials.
GCP training aims to ensure that:
- the rights, safety, and well-being of human subjects are protected
- clinical trials are conducted in accordance with approved plans with rigor and integrity
- data derived from clinical trials are reliable
Training in GCP may be achieved through the Good Clinical Practice (GCP) CITI module.