PB HLTH X400.5
This course offers a comprehensive overview to full data lifecycle from vendor selection and data management setup through data entry, review, cleanup, statistical analysis, and clinical study report (CSR) development vendor selection. Students will learn how sponsors and Clinical Research Organizations (CROs) strengthen regulatory compliance, how investigational sites prepare for audits, and what to expect during Food and Drug Administration (FDA) and global regulatory inspections, including potential findings and outcomes. Learners will gain practical experience identifying key components of data analysis plans (DAPs), understanding documentation workflows, and examining how clinical study reports and new drug applications (NDAs) are structured, compiled, and finalized.
Prerequisites:
Introduction to Clinical Research: Clinical Trial Phases and Design PB HLTH X400.2; Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities PB HLTH X400.3; and Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting PB HLTH X400.4
Course Objectives
What You Learn
How You Learn
Summer 2026 enrollment opens on March 16!
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