Please be aware that the changes to the federal regulations that govern human subjects research go into effect on January 21st, 2019. Please see our Standard Operating Procedures for this transition to see how these changes will affect your research.
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.
If you will access Protected Health Information (PHI), which includes medical records, you will also need to complete the "CITI Health Information Privacy & Security (HIPS)" training.
If you are conducting research on a medical device, drug, biologic, or an in vitro diagnostic, you will also need to complete the CITI course for "Good Clinical Practice (GCP)." If your study is funded by the NIH, then GCP training is also needed if you are conducting a clinical trial as defined by the NIH.
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.
Step-by-Step Instructions for Completing CITI Modules
Training certificates from Georgia Tech faculty, students, and staff are automatically updated in the individuals' profiles in IRBWISE by the following day. Do not delay submitting a protocol or amendment while waiting for training certification to appear. Certificates can be manually updated by the ORIA staff if the automatic update does not go through, or if the training was completed at another institution. If the training was completed at another institution, please either upload your certificate to the submission or email the ORIA staff at IRB@gatech.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.
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.