Investigator-initiated Trials Operations
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Table of Contents
Table of Contents
This course provides educational information and does not replace professional medical advice, diagnosis, treatment, or clinical judgment.
Investigator-initiated trials (IITs) empower clinical researchers to generate evidence that addresses real-world questions beyond commercial interests, yet their operational complexity often hinders successful execution.
What You Will Learn
- 1 Learn the regulatory and ethical foundations of investigator-initiated trials
- 2 Understand the process of developing a scientifically sound protocol
- 3 Apply regulatory submission strategies for IND/CTA and ethics committee approvals
- 4 Analyze site selection criteria and management practices for efficient trial conduct
- 5 Implement data management and quality assurance systems for IITs
- 6 Explore safety monitoring and adverse event reporting requirements
- 7 Develop budgeting and financial management skills for academic trials
- 8 Understand monitoring and oversight responsibilities in IITs
- 9 Apply close-out procedures and archival documentation standards
- 10 Build a quality management framework tailored to investigator-initiated research
What's Included
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Investigator-initiated Trials Operations