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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

Applies Towards the Following Certificates or Series

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Enroll now - Select a section

Section Title
Clinical Research Advanced Topics
Type
Discussion
Days
W
Time
8:00PM to 9:00PM
Dates
Oct 28, 2020
Type
Discussion
Days
W
Time
6:00PM to 9:00PM
Dates
Nov 04, 2020
Type
Discussion
Days
W
Time
6:00PM to 9:00PM
Dates
Nov 18, 2020
Schedule and Location
Contact Hours
7.0
Course Fee(s)
Non-Credit Course Fee non-credit $850.00
Instructors
  • Molly Adamek
  • Diana Martin
  • Stacy Mercado
  • Dr. Ian Pagano
  • Dr. Joe W. Ramos
  • Dr. Lynne Wilkens
Section Notes

Certificate program is online via Zoom.

Email CRPcertificate@cc.hawaii.edu for program-related questions. For registration assistance, please contact hagal@hawaii.edu.

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