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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.

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Prerequisites

Good Clinical Practices and The Drug Development Process

Instructors

Applies Towards the Following Certificates

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Enroll Now - Select a section to enroll in
Section Title
Fundamentals of Clinical Monitoring
Type
Online, self-paced
Dates
Aug 30, 2021 to Sep 29, 2021
Type
Online, fixed date
Days
W
Time
7:30PM to 9:00PM
Dates
Sep 01, 2021 to Sep 29, 2021
Schedule and Location
Contact Hours
7.5
Location
  • Online
Delivery Options
Course Fee(s)
Tuition Fees non-credit $1,400.00
Instructors
Section Title
Fundamentals of Clinical Monitoring
Type
Online, self-paced
Dates
Jan 24, 2022 to Feb 23, 2022
Type
Online, fixed date
Days
W
Time
7:30PM to 9:00PM
Dates
Jan 26, 2022 to Feb 23, 2022
Schedule and Location
Contact Hours
7.5
Location
  • Online
Delivery Options
Course Fee(s)
Tuition Fees non-credit $1,400.00
Instructors
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