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340.633.01 DATA MANAGEMENT IN CLINICAL TRIALS

Department: Epidemiology
Term: 3rd term
Credits: 3 credits
Contact: Dave Shade
Academic Year: 2012 - 2013
Course Instructor:
Description:

Acquaints students with important principles of the acquisition, management, and distribution of data in the clinical research environment. Topics focus 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. Does not focus on any particular type or size of study but 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. Discussions often stress the benefits and costs of alternatives rather than recommending particular courses of actions. Does not focus on computer programming, although it combines practical and hands-on exercises with advanced treatment of important concepts.

Learning Objective(s):
Upon successfully completing this course, students will be able to:
explain basic and advanced concepts of data management
make reasonable decisions about how to collect and manage data for studies of various sizes and budgets
evaluate alternative courses of action and policies regarding data collection and management issues in a trial
integrate data management activities into the conduct of a research project
communicate with or supervise other study staff involved with data management issues

Methods of Assessment: class participation, short written assignments, a written examination, and a final project.
Location: East Baltimore
Class Times:
  • Tuesday 1:30 - 2:50
  • Thursday 1:30 - 2:50
Enrollment Minimum: 5
Enrollment Maximum: 25
Instructor Consent: No consent required
Prerequisite:

340.645 (Introduction to Clinical Trials) OR 550.711 (Methods in Clinical Research) OR 140.642 (Design of Clinical Experiments) OR permission of the instructor

Auditors Allowed: No
Grading Restriction: Letter Grade or Pass/Fail
Special Comments: Replaces 340.856 (SS/R Data Mgmt in Clinical Trials).