Good Clinical Practice (GCP) includes basic courses tailored to the different types of clinical research. These courses also include corresponding refresher courses for retraining and advanced learning.
CITI Program GCP training is used by over 1,500 institutions - (including many leading hospitals, academic medical centers, universities, and healthcare companies) - to meet their GCP training needs. The National Institutes of Health (NIH)* requires completion of GCP training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants.
GCP courses cover applicable U.S. FDA regulations, ICH E6(R2) GCP principles and practices, and the ISO 14155:2020 standard.
The following GCP ICH E6 Investigator Site Training courses also meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors and have been updated to include ICH E6(R2):
Basic Courses - English with ICH E6(R2)
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
Refresher Courses - English with ICH E6(R2)
- GCP FDA Refresher
- GCP ICH Refresher
- GCP SBR Advanced Refresher
These courses were written and peer-reviewed by experts.
* NIH in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) states that NIH-funded investigators and staff should be trained in GCP. The NIH does not endorse any specific training programs. CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH policy released on 16 September 2016.
Language Availability: Chinese, English, Korean, Spanish, Finnish, French, German
Suggested Audiences: Clinical Research Coordinators, Contract Research Organizations (CROs), Investigators, IRB Members, Key Study Personnel, Principal Investigators, Research Nurses, Research Staff, Researchers, Sponsors, Study Coordinators