Good Clinical Practice: A Vaccine Trials Perspective

4 Credits.

Acquaints students with the regulatory and ethical standards of conducting trials in accordance with FDA Code of Federal Regulations and ICH GCP Guidelines. Provides students with background and resources needed to conduct clinical trials in healthy populations. Students complete a project based on a real-world vaccine trial focusing on logistical and operational components of protocol design, informed consent process, recruitment considerations, human subjects protection including adverse event assessments and reporting. Additional concepts include the responsibilities of ethical review committees, principal investigators, and sponsors; investigational product management and preparation; data collection methods; quality assurance and quality control (QA/QC). Contributors to the course have experience conducting clinical trials research in various settings.