DATA MANAGEMENT IN CLINICAL TRIALS Syllabus
Course Learning Objectives
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
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.
Students who anticipate conducting or working on clinical studies; students interested in principles and methods of data management.
Methods of Assessment
Grading Policy: class participation, short written assignments, a written examination, and a final project.
Grading Restrictions: Letter grade
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
Academic Ethics Code
The code, discussed in the Policy and Procedure Memorandum for Students, March 31, 2002, will be adhered to in this class:
Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.
Disability Support Services
If you are a student with a documented disability who requires an academic accommodation, please contact Betty H. Addison in the Office of Student Life Services: firstname.lastname@example.org, 410-955-3034, or 2017 E. Monument Street.