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Berkeley Global
The last in a series of four courses, this final course focuses on the clinical study report and other procedures at study close-out. You will be prepared to conduct regulatory audits and inspections. You’ll also gain an overview of project management and vendor selection as they pertain to clinical research.
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 Outline
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Course Objectives
- Describe how sponsors and CROs may improve regulatory compliance
- Describe how investigational sites may prepare for regulatory audits, the procedures to expect at an audit, the possible findings and outcomes
- Understand the role of project management in clinical research
- Understand the vendor selection process
- List the sections of a data analysis plan (DAP) and describe how it is developed and finalized
- Understand data entry, review and cleanup procedures
- Describe clinical trial data analyses and report writing procedures
- List the sections of a clinical study report (CSR) and describe how it is developed and finalized
- Describe the sections of a new drug application (NDA) and the procedures for compiling the sections and filing an NDA.
What You Learn
- Quality assurance
- Quality control
- CQA sponsor perspective
- Regulator inspections
- Inspection readiness
- Project management in clinical trials
- Vendor selection
- Study initiation: data management setup
- Study execution: data collection
- Post-Study: data analysis and quality assurance
- Clinical study reports
- New drug application
How You Learn
- Multimedia lectures
- Reading assignments
- Research discussion assignments
- In-depth questions
- Case studies
- Midterm and final exams
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