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340.633.41
Data Management in Clinical Trials

Location
Internet
Term
3rd Term
Department
Epidemiology
Credit(s)
3
Academic Year
2024 - 2025
Instruction Method
Synchronous Online
Class Time(s)
M, W, 1:30 - 2:50pm
Auditors Allowed
Yes, with instructor consent
Available to Undergraduate
Yes
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
Prerequisite

340.645 (Introduction to Clinical Trials) OR 140.642 (Design of Clinical Experiments) OR permission of the instructor

Description
Acquaints students with important principles of the acquisition, management, and distribution of data in the clinical research environment. Focuses on real-world needs of investigators and emphasizes those issues that researchers need to understand to work effectively with other members of study teams, including coordinators, data entry staff, programmers, and data managers. Covers topics that apply to many studies, and discusses approaches ranging from small single-investigator trials using only a spreadsheet through international networks using sophisticated web-based data management systems, although does not focus on any particular type or size of study. Discusses the benefits and costs of alternatives rather than recommending particular courses of actions. Combines practical and hands-on exercises with advanced treatment of important concepts, although it does not focus on computer programming.
Learning Objectives
Upon successfully completing this course, students will be able to:
  1. Explain basic and advanced concepts of data management
  2. Make reasonable decisions about how to collect and manage data for studies of various sizes and budgets
  3. Evaluate alternative courses of action and policies regarding data collection and management issues in a trial
  4. Integrate data management activities into the conduct of a research project
  5. Communicate with or supervise other study staff involved with data management issues
Methods of Assessment
This course is evaluated as follows:
  • 10% Participation
  • 65% Assignments
  • 25% Exam(s)
Special Comments

This is the virtual/online section of a course also held onsite. You are responsible for the modality in which you register.