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Department of Health Informatics

Clinical Research Management

BPHE7600 - Analyzing Clinical Data for Adverse events

Course Description

This course focuses on drug induced medical problems and the analysis of adverse events by organ systems. Students will utilize the principles of pharmacokinetics and pathophysiology to predict and explain adverse events as well as to establish causality and clinical significance.

Credits/Modes of Instruction

Credits: 3

This course is 3-credits and runs 10 weeks, with each week beginning on a Sunday and ending on the following Saturday. This course is a graduate course provided via the internet using the Canvas Platform. Modes of instruction and course format include assigned readings, links to relevant sites on the internet, narrated PowerPoint slideshows (streaming audio or MP3 files), and directed discussion activities, written assignments and real-time video web conferencing meetings to review class materials. All session assignments, PDF formatted handouts, web-conference sessions, video links, podcasts, hyperlinks, readings and other information will be available at the course website or through the University Library Resources website.

Prerequisites

BPHE 7510 Clinical Pharmacology or NUTR 7510 Nutrition and Pharmacology.

Course Goals and Outcomes:

Goals

To teach students how to recognize Adverse Drug Reactions and to determine their clinical significance.

Outcomes

Understand the regulatory importance of analysis of clinical data and its application; Explain pharmacokinetics and how it is affected by different disease states to produce adverse events; Identify major drug induced adverse events (AEs) or safety signals and provide the rationale for their development; Explain the pharmacogenetic basis for Adverse Drug Reactions (ADRs); Analyze laboratory values and results of other medical tests. 6. Interpret clinical data to determine clinically significant AEs.