Fellowship Cinical Trial Education Series for 2012-2013
- Series Syllabus (revised January 2013)
- Overview of NIH, NCI, CCR
- Good Clinical Research Practice and Human Subject Protection + Milestones in the History of HSP
- Clinical Trial Design
- U.S. Drug Development and Regulatory Oversight of IND Clinical Trials
- Role of the Sponsor
- Protocol Development, Review and Approval Process
- Statistical Considerations in Trial Design and Data Analysis
- Roles of the Research Team
- Informed Consent
- Documentation and Document Management in Clinical Research
- Clinical Data Management
- Documenting, Recording, and Reporting of Adverse Events (AEs) and Unanticipated Problems
- REICST: Applying the Rules
- Clinical Trial Monitoring