Рет қаралды 910
The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.
Participants will acquire a practical understanding of:
• FDA’s approach to trial design
• Statistical issues in the analysis of trial data
• Safety concerns in the development of medical products
• Understanding preclinical information relevant to medical product development
• Clinical investigator responsibilities
Timestamps
No time stamps
Speakers:
Leonard Sacks, MD
Director
Clinical Methodologies
Office of Medical Policy (OMP) | CDER | FDA
Learn more at: www.fda.gov/dr...
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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