General Training Requirements
Completion of the Good Clinical Practice (GCP) Collaborative Institutional Training Initiative (CITI) course is required for all Georgia Tech investigators who will conduct a clinical trial as defined by the FDA, OHRP, or NIH, and/or conducting research on a medical device, drug, biologic, or an in vitro diagnostic involving human subjects or human subjects specimen(s). If your study is an NIH funded socio-behavioral clinical trial, then you will need to complete the CITI course for “GCP – Social and Behavioral Research Best Practices for Clinical Research." Additional training may be required depending on the specifics of your research, including but not limited to specific training requirements for human subjects research and animal research.
Effective May 8th, 2023: To access the CITI training website, all users (both GT and non-GT) will need to use the GT Single Sign-On (SSO) process. GT users will need to click the link above to access CITI. Non-GT users will have to use an existing GT affiliation in CITI or will have to request a GT guest account so they can obtain CITI access and affiliate with GT. To request a guest account, please go to the Responsible Conduct of Research website and click "Submit Request for Georgia Tech CITI Access."
Step-by-Step Instructions for Completing CITI Modules
An instructional guide has been created to provide step-by-step instructions for completing CITI modules. Please note that Training certificates from everyone who uses the Georgia Tech single sign-on 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
NIH - Good Clinical Practice Requirement
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.
Purpose
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.