Good Clinical Practice training provides an overview of essential elements of GCP needed by research teams involved in clinical trials. This training covers key areas, including investigator and sponsor obligations, how to manage investigational agents, audits and inspections, adverse event detection and evaluation, and the monitoring of clinical trials.
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.
Suggested Audiences: Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Investigators, IRB Members, Key Study Personnel, Principal Investigators, Research Nurses, Research Staff, Researchers, Sponsors, Study Coordinators
