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
263-7390
fisher@biostat.wisc.edu

Class

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.

Prerequisite

Biostatistics 541 and 542