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Practical Skills in Conducting Research in Clinical Epidemiology and Investigation

East Baltimore
1st term
3 credits
Academic Year:
2021 - 2022
Instruction Method:
Class Times:
  • Tu Th,  10:30 - 11:50am
Auditors Allowed:
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructors:
Heather McKay

340.752 Epidemiologic Methods II and 140.622 Statistical Methods in Public Health or 140.652 Methods in Biostatistics    


Emphasizes the practical aspects of conducting and organizing a clinical research project. Focuses on developing skills to develop and manage a research protocol, monitor the data collection, manage the data, and disseminate results. Lectures cover the basic components of a clinical research team, the components of good clinical research practice, the responsibilities, expertise and tasks that each research team member is expected to perform, and organizational, logistical and attitudinal issues that need to be addressed when creating an effective research group. Additionally, explores translational research and the kinds of issues that arise when multi-disciplinary teams are brought together.

Learning Objectives:

Upon successfully completing this course, students will be able to:

  1. Identify the required components of a clinical research study
  2. Prepare an informed consent for a clinical research study
  3. Develop a plan for conducting clinical research
  4. Construct a recruitment strategy
  5. Distinguish among basic data collection procedures
  6. Develop data collection forms
  7. Assess quality assurance procedures for specific clinical study designs
  8. Understand the foundations of data harmonization and the use of summary data files
  9. Distinguish and identify reporting requirements for clinical studies
Methods of Assessment:

This course is evaluated as follows:

  • 10% Participation
  • 40% Assignments
  • 50% Final Project

Enrollment Restriction:

Restricted to graduate students.

Instructor Consent:

Consent required for all students

Consent Note:

Permission must be obtained directly from Fran Burman ( and Lisa Jacobson prior to enrollment

For consent, contact: