Course Description

Course work includes an in depth study of drug development, data management, FDA regulations for research with novel agents, and clinical trial biostatistics. This course also includes a clinical research “journal club” where participants will learn to interpret and analyze published clinical trials articles.

Course Outline

Topics to include:

  1. Clinical Trial Biostatistics
  2. Types of Trial Design
  3. Data Management
  4. IND
  5. Investigational Drugs
  6. FDA's Role in Public Health: Drug Efficacy, Safety, and Beyond
  7. Drug Development Pipeline
  8. FDA

Learner Outcomes

  1. Clinical Trial Biostatistics
  • Learn basic research methods and data collection strategy
  1. Data Management
  • Learn the fundamentals of data management
  • Understand the typical flow of data in a clinical research study
  • Learn tools commonly used by data managers
  1. Investigational New Drug (IND)
  • Gain an understanding of the IND process including regulatory considerations when filing an IND application
  1. Drug Development Pipeline
  • Learn about the characterization of the disease process and identification of drug targets


"An exemplary program that allows you to dip your feet into the world of Clinical Research. With truly passionate providers to guide and mentor you, this program is fit for all who are wanting to find the confidence to take their career to the next level."~Cheyenne Tashombe, Hawaii Pacific Neuroscience

Applies Towards the Following Certificates or Series

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