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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 27, 2021
Type
Discussion
Days
W
Time
6:00PM to 9:00PM
Dates
Nov 03, 2021
Type
Discussion
Days
W
Time
6:00PM to 9:00PM
Dates
Nov 10, 2021
Schedule and Location
Contact Hours
7.0
Delivery Options
Online  
Course Fee(s)
Non-Credit Course Fee non-credit $850.00
Section Notes

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

Section Notes: Certificate program is online via Zoom.

The course will be held via Zoom. Before joining a Zoom meeting on a computer or mobile device, you can download the Zoom app from the Zoom Download Center. Otherwise, you will be prompted to download and install Zoom when you click on the link, which will be provided to you prior to the online seminar. You will also receive a digit-number (Meeting ID), which is necessary to join the online course.

For more information on how to join a Zoom meeting, click here.

You can also find Zoom's system requirements here.

 

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