Course Description

The purpose of this course is to introduce you to the process and procedures of monitoring a clinical trial as a clinical research associate working for a pharmaceutical or device manufacturer (known as the sponsor). The course is focused on trials conducted under U.S. FDA applications (INDs and IDEs). The process of monitoring begins with creating a risk-based monitoring plan and progresses through selecting qualified investigators, executing the assessments defined in the monitoring plan, changing the plan and actions when problems and issues are identified, and closing the sites as their study participation concludes. Sponsors follow Standard Operating Procedures for monitoring clinical trials, which are based on the FDA regulations as found in 21 CFR, Parts 11,50, 54, 56, 312, and 812 and in guidance documents, such as the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP) E6 and Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring.

Online self-paced”: Refers to course start and end dates. “Online fixed date”: Refers to synchronous session schedule fully available under “Section Notes”.

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Good Clinical Practices and The Drug Development Process


Applies Towards the Following Certificates

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Section Title
Fundamentals of Clinical Monitoring
Online, self-paced
Feb 12, 2024 to Mar 13, 2024
Online, fixed date
7:00PM to 8:30PM
Feb 14, 2024 to Mar 13, 2024
Schedule and Location
Contact Hours
  • Online
Delivery Options
Course Fee(s)
Tuition Fees non-credit $1,435.00
Section Notes

Synchronous Sessions are Wednesdays from 7:0-8:30 PM CST on February 14, 21, 27*, March 5*, and 13.

* The Sync session runs on Tuesdays weeks 3 and 4.

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