Course Overview

This course explains the FDA inspection process, identifies common deficiencies and regulations guiding FDA inspections and identifies the sponsor’s responsibilities in monitoring study sites. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.

You should expect to spend approximately 2 hours of study time to complete the course.

Course Objectives

  • Identify the Sponsor’s responsibilities for monitoring study sites.
  • Explain the FDA inspection process and identify areas of common deficiencies.

Who Should Attend

  • Study site investigators
  • Site monitors and auditors
  • Research nurses
  • Regulatory affairs associates
  • Data management personnel
  • Pharmacists

Download Course Outline

  • Monitoring of Clinical Studies
  • Clinical Quality Assurance (CQA)
  • FDA Inspections

This course is currently under review for reaccreditation and is not accredited at this time.

Minimum Hardware Requirements
Windows 98/2000/NT/XP
Mac computer with an Intel processor
Pentium III processor at 500 MHz
128 MB RAM

Minimum Software Requirements
Web browser such as Google Chrome, Internet Explorer 6+, Safari
Adobe Acrobat Reader and Flash plug-ins
Access to the Internet with any connection 56K or above

PERI, Inc. is the sole owner of the information collected at various points on this site. We will not sell, share, or rent this information to others in ways different from what is disclosed in this statement.

Course Details

Third Course in the Good Clinical Practices for the Clinical Research Team Series (see overview)
2-Month Access
Single Price: $160.00

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Contact one of our course instructors to ask a specific question about the program.

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Our Students

  • “I have learned information that will change the way I work with my clinical team.”

  • “This course allows me to better understand the clinical language used during meetings and to assist with 
preparation of clinical trials.”