CLINICAL TRIALS MANAGEMENT Syllabus
Course Learning Objectives
Upon successfully completing this course, students will be able to:
- Apply competencies gathered throughout this and other epidemiology or biostatistics courses on key components of multicenter clinical trials
- describe developing strategies applicable at most participating centers in a Multicenter setting including writing study policies and procedures
- conduct multicenter trials
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.
Masters and doctoral candidates and other individuals involved in or expected to be responsible for running clinical trials.
Methods of Assessment
Grading Policy: Project, homework assignments, class discussion & participation
Grading Restrictions: Letter grade
Students may take either 340.601 or 340.751, but they must also take 340.645.
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: email@example.com, 410-955-3034, or 2017 E. Monument Street.