Non-Scientist IRB Members Track

Breakout Session Series C

C15 - Scientific Aspects of Study Design: A Primer for Non-Scientists

Speaker(s)

• 

  Susan Fish, PharmD, MPH

  Professor, Biostatistics
  Boston University School of Public Health
  Boston University
• 

  Lindsay McNair, MD, MPH, MSB

  Chief Medical Officer
  WIRB-Copernicus Group

This session will serve as a primer on the scientific process, clinical study designs, and the structure of research programs for the non-scientist IRB member. During this session, speakers and attendees will:

Learning Objectives:

• Discuss the essential components of a study question and how the question can be addressed in a clinical study
• Review the basics of both observational and interventional clinical study designs, and the strengths, weaknesses, and application of each design
• Explain the essential considerations that can impact the validity of a clinical study and the analysis of study data
• Note: This session will end at 1:30 PM. Attendees should get their boxed lunch in the exhibit hall before going to the session room.