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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 Resaerch 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.
Step-by-Step Instructions for Completing CITI Modules
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.
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 Resaerch Best Practices for Clinical Research CITI module.