GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) is organized by Collaborative Institutional Training Initiative (CITI Program).
Description :
The GCP ICH Basic course covers International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) guideline essential topics for clinical trials with drugs and biologics. It describes the responsibilities and expectations for the conduct, monitoring, reporting, and documenting of clinical trials. It is intended for research personnel involved in drug and biological studies who would benefit from more internationally focused training, or for researchers involved in studies where compliance with ICH is required (for example, most industry-funded studies). It should be noted, however, that when appropriate, references to U.S. Food and Drug Administration (FDA) regulations and guidance are included.
Objectives :
The course covers key topics in clinical research including:
• Reviewing ICH GCP standards
• Reviewing FDA regulations
• Identifying investigator and sponsor obligations
• Discussing new drug development
• Comparing ICH GCP E6 guidelines and FDA regulations
• Describing how to detect and report adverse events
• Auditing and monitoring expectation
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.
