Fabrizio Fazzi
This course introduces good clinical practice (GCP) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines. Topics include conducting clinical trials in accordance with GCP, regulations established by state, federal, and international regulatory bodies, and the roles and responsibilities of investigators, sponsors, monitors, and auditors.
Skills / Knowledge
- Define the term GCP
- Describe the need for GCP
- List the parts in the Code of Federal Regulations (CFR) about GCP
- List the members of a research team and describe their roles and responsibilities
- Describe ethical considerations of conducting clinical research
- Describe how the rights and safety of human subjects are protected
- Identify the elements of good protocol design
- Know the federal registry for clinical trials, ClinicalTrials.gov
- Define standard clinical research terms and acronyms
- Demonstrate knowledge of non-compliance with GCP
- Describe the consequences of failure to comply with GCP
Issued on
January 30, 2025
Expires on
Does not expire