GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) is organized by Collaborative Institutional Training Initiative (CITI Program).
Objectives :
The GCP U.S. FDA Basic course covers Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) essential topics for clinical trials with investigational drugs, biologics, and/or medical devices. It is intended for research personnel involved in drug, biological, or device studies and who would benefit from FDA-focused training. It covers key topics in clinical research including:
• Reviewing FDA regulations
• Identifying investigator and sponsor obligations
• Discussing new drug development
• Comparing International Council for Harmonisation (ICH) GCP E6 and FDA regulations
• Describing how to detect and report adverse events
• Auditing and monitoring expectations
This course (English only) meets 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.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.
