General Training Requirements
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 a study is accessing Protected Health Information (PHI), which includes medical records, all study personnel will also need to complete the "CITI Health Information Privacy & Security (HIPS)" training.
If a study is considered to be a clinical trial as defined by the FDA, OHRP, or NIH, and/or is conducting research on a medical device, drug, biologic, or an in vitro diagnostic involving human subjects or human subjects specimen(s), all study personell will also need to complete the CITI course for "Good Clinical Practice (GCP)." If the study is an NIH funded socio-behavioral clinical trial, then all of the study personnel will need to complete the CITI course for “GCP – Social and Behavioral Research Best Practices for Clinical Research."
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 and the GCP – Social and Behavioral Research Best Practices for Clinical Research CITI module.