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Course Catalog

140.633.81 BIOSTATISTICS IN MEDICAL PRODUCT REGULATION

Department: Biostatistics
Term: 1st term
Credits: (2 credits)
Academic Year: 2012 - 2013
Course Instructors:
Description:

Provides a broad understanding of the application of biostatistics in a regulatory context. Reviews the relevant regulations and guidance documents. Includes topics such as basic study design, target population, comparison groups, and endpoints. Addresses analysis issues with emphasis on the regulatory aspects, including issues of missing data and informative censoring. Discusses safety monitoring, interim analysis and early termination of trials with a focus on regulatory implications.
Student Evaluation: Class quizzes and exercises
Learning Objective:

Upon successfully completing this course, students will be able to: 1) explain the relevance and application of statistics to the regulatory process; 2) differentiate between well-designed and conducted clinical research in the development and evaluation of new medical products; 3) locate internet sources for regulatory requirements, and regulatory review and evaluation information.
Location: Internet
Enrollment Minimum: 10
Instructor Consent: No consent required
Prerequisite:

Introduction to Online Learning is required prior to participating in any of the School's Internet-based courses. Basic epidemiology and biostatistics
Grading Restriction: Pass/Fail
Catalog Subcommittee Actions: FrequencySchedule, FrequencyId, CourseLocation, IRBSurvey, GradingRestriction, AuditorsAllowedId, CourseOfferRationaleNote, ContactPerson, ContactEmail, StartingOfferYear, RepeatableRetakable, ScheduleTypeId, StartDate, EndDate, LabScheduleTypeId, CPInstructor, .02/04/2011;