Course Overview

This course is designed to interpret FDA regulations and ICH guidelines to apply to informed consent, adverse event and drug accountability reporting, ethical conduct during clinical research and to define the IRB/ED’s. 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 3 hours of study time to complete the course.

Course Objectives

  • Interpret FDA regulations and ICH guidelines pertaining to GCPs
  • Apply GCP regulations and guidelines to your processes around informed content, adverse event reporting, records and reports, and drug accountability
  • Describe the IRB/EC responsibilities for ensuring the ethical conduct of clinical research

Who Should Attend

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

Download Course Outline

  • Regulatory Environment in the United States
  • International GCP Regulations
  • Institutional Review Boards/Ethics Committees

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

First Course in the Good Clinical Practices for the Clinical Research Team Series (see overview)
2-Month Access
Single Price: $240.00

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

  • 1 “This course filled in gaps in knowledge of clinical regulatory issues.”

  • 2 “This course will help in my responsibilities of writing/submitting regulatory documents.”