340.648.01
Clinical Trials Management

Discontinued

Location
East Baltimore
Term
4th Term
Department
Epidemiology
Credit(s)
3
Academic Year
2023 - 2024
Instruction Method
In-person
Class Time(s)
Tu, Th, 2:00 - 3:20pm
Auditors Allowed
Yes, with instructor consent
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Ann-Margret Ervin
Contact Name
Ann Ervin
Frequency Schedule
Every Year
Prerequisite

Students may take either 340.601 or 340.751, but they must also take 340.645. (n.b. Some concepts covered in this course are also covered in 340.660 offered 1st term.)

Description
Provides an overview of methods related to the day-to-day conduct of multicenter randomized clinical trials with an emphasis on the Coordinating Center perspective. Using case studies of multicenter clinical trials for illustration, emphasizes topics related to practical applications such as organizational models, use of standardization, and performance monitoring. Discussion of methods is encouraged, including alternatives to usual practice.
Learning Objectives
Upon successfully completing this course, students will be able to:
  1. Apply competencies gathered throughout this and other epidemiology or biostatistics courses on key components of multicenter clinical trials
  2. Describe developing strategies applicable at most participating centers in a multicenter setting including writing study policies and procedures
  3. Conduct multicenter trials
Methods of Assessment
This course is evaluated as follows:
  • 50% Group Project(s)
  • 20% Homework
  • 15% Group Presentation
  • 15% Quizzes
Instructor Consent
No consent required
Special Comments

can substitute for 340.660 Practical Skills in Conducting Research for 2019-2020.