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Training and Student Information
Biostatistics Courses
544 Introduction to Clinical Trials ll

Course Description

This course will provide practical experience and training in clinical trial research. The course will focus on the design, implementation, and conduct of clinical trials. Topics include: regulatory requirements for clinical trials; data collection strategies, data quality and management; budget development and justification; federal, institutional, and sponsor-defined requirements; establishment of research infrastructures for safety and success; preparation of investigator-INDs; investigator responsibilities in Phase l-IV trials. Development of data collection and data management systems and a budget for the protocol developed in 541 are required components of this course.

Course Director

Marian Fisher, PhD, Research Professor of Biostatistics & Medical Informatics
215 WARF Building


Two lectures per week for one hour and 15 minutes each, Tuesday and Thursday 4:45-6:00pm.
The final week is reserved for presentation of individual class projects.


Biostatistics 541 and 542

Uw Madison, Chemistry Lab UW Madison, Class held outside on Bascom Hill
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