Week One: The Research Question

This module focuses on the first step in designing a clinical study: deciding the question you want to answer. There are many issues to consider when developing a research question to assure that the study results will address your primary area of inquiry. This module introduces a step-by-step process of developing and refining the research question and using it as the foundation for moving forward in the design of a clinical study.

 Objectives

After completing this module, students should be able to:

• Identify and describe the characteristics of a good research question.
• Explain three key ingredients for developing a research question.
• Name and briefly describe each of the FINER criteria.
• Describe several sources from which good research questions arise.
• Draft a one-sentence research question and a 1/2 page description describing its significance.

 Reading

In Designing Clinical Research, 4th Edition, by Hulley et al.

• The Introduction
• Chapter 1: Getting Started: The Anatomy and Physiology of Clinical Research
• Chapter 2: Conceiving the Research Question and Developing the Study Plan

Optional reading: An article by Lori Lingaard on the "Problem, Gap, Hook" approach to writing introduction sections for clinical research reports or proposals.

 Lecture

Small Group Sections

 Assignments

 Optional Exercises