Effective January 1, 2017, training in Good Clinical Practice (GCP) is required for all research personnel involved in the conduct, management and oversight of a clinical trial. The NIH definition of a clinical trial is, " a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."
GCP principles constitute an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. The principles were developed in 1996 by the International Conference on Harmonisation (ICH) in collaboration with representatives from the European Union, Japan, and the United States. The US Food and Drug Administration (FDA) requires GCP compliance for studies conducted under an investigational new drug application or investigational device exemption.
GCP principles describe the responsibilities of investigators, sponsors, monitors and IRBs in the conduct of clinical trials. Compliance with these GCP principles provides assurance that the rights, safety and well-being of human subjects are protected, that clinical trials are conducted in accordance with approved plans with rigor and integrity and that data derived from clinical trials are reliable.
There are multiple options for fulfilling the GCP training requirement:
GCP Training should be refreshed at least every three years in order to remain current with regulations, standards and guidelines. If you have already completed GCP training, you can upload your completion certificate on the GCP Portal Page
IRB approval of any clinical trial will not be issued unless all research personnel are in compliance with the GCP education requirements.
This GCP training is in addition to the current Human Subjects' training already required by the IRB for those who work in human subject research and trials.
If you need GCP training, the Clinical & Translational Research Program is pleased to offer training through the Association of Clinical Research Professionals (ACRP). The courses can be accessed by using the link below.
Numerous modules are available to meet the needs of your position and research program. For example, experienced investigators and staff may take a “test out challenge” while those new to research can use the introductory modules.
This training was created by the Association of Clinical Research Professionals and meets the requirements of the NIH and other sponsors. The training offered at Lurie Children’s has also been implemented at Northwestern University via the NUCATS Institute. NUCATS participated in a multi-CTSA initiative, led by Dr. Shanley, to implement GCP training at Clinical and Translational Science Award Programs.
Please feel free to explore the content and begin the training whenever you wish. The system will track and save your information as you go.
For questions regarding accessing or using the GCP modules, please contact: GCP@Luriechildrens.org
GCP Portal Page: (Upload your certificates here)