Clinical Trial Management
About This Course
Master the art of running successful clinical trials from start to finish. This course takes you through every step of clinical trial management, showing you how to design protocols that get approved, manage sites effectively, and ensure your data meets regulatory standards. You'll learn how to avoid the common mistakes that delay trials and cost companies millions. We cover everything from selecting the right sites and investigators to handling adverse events and preparing for FDA inspections. Whether you're managing a small Phase I study or coordinating a large Phase III trial across multiple countries, this course gives you the tools and knowledge to succeed. You'll understand GCP requirements inside and out, learn how to maintain quality data, and discover strategies for keeping trials on time and on budget.
What's Included
Course Format
Self-paced, on-demand learning with lifetime access. Complete at your own speed with no deadlines.
Key Topics Covered
What You'll Learn
- Design and implement clinical trial protocols
- Ensure GCP compliance throughout trial lifecycle
- Manage clinical trial data and documentation
- Coordinate multi-site clinical studies
- Navigate regulatory requirements for clinical trials
Course Outcomes
By the end of this course, you will be able to:
- Design protocols for all trial phases
- Ensure GCP compliance throughout trial lifecycle
- Manage clinical trial data effectively
- Coordinate multi-site clinical studies
- Navigate regulatory requirements confidently
Who Should Take This Course
- Clinical research associates
- Clinical trial managers
- Regulatory affairs professionals
- Medical writers
- Quality assurance specialists
Course Content
Module 1: Clinical Trial Fundamentals
- Clinical trial phases overview
- Protocol development
- Regulatory requirements
Module 2: GCP Compliance
- Good Clinical Practice guidelines
- Informed consent processes
- Adverse event reporting
- Audit and inspection readiness
Module 3: Trial Management
- Site selection and management
- Investigator responsibilities
- Data collection and management
- Monitoring and quality assurance
Module 4: Regulatory Submissions
- IND/CTA submissions
- Protocol amendments
- Safety reporting
- Study closeout and reporting
This course is delivered through Thinkific. You'll receive access instructions after enrollment.