Course Overview

This course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. The curriculum will emphasize GCP requirements and quality assurance functions for clinical trials from several perspectives, including those of the sponsor-monitor and the quality assurance group, institutional review boards (IRB)/ethics committees (EC), and the clinical investigators. GCPs will be discussed from the regulatory perspectives of FDA and ICH.

You should expect to spend approximately 15 hours of study time to complete the course.

Course Objectives

  • Interpret FDA regulations and International Conference on Harmonization (ICH) guidelines pertaining to GCPs.
  • Identify the regulatory, source documentation, and recordkeeping requirements for clinical trials.
  • Describe the components of internal auditing systems.
  • Explain the roles and responsibilities of sponsor, monitor, investigator, and regulatory authorities in ensuring the proper conduct of clinical trials.
  • Apply GCP principles to the collection and reporting of adverse events.

Who Should Attend

  • Quality assurance associates
  • Regulatory compliance professionals
  • Clinical research associates
  • Medical monitors
  • Pharmacists

Download Course Outline

  • Regulatory Environment in the US
  • International GCP Regulations
  • Institutional Review Board (IRB)/Ethics Committee Responsibilities
  • Investigator Responsibilities
  • Sponsor Responsibilities
  • The Protocol
  • Sponsor Obligations
  • Monitoring Responsibilities
  • Clinical Quality Assurance (CQA) Group
  • FDA Inspections
  • Managing 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

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Course Details

Online Course
4 Month Access
$590.00 Registration Fee

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Our Students

  • 1 “I will be able to better reference the Guidances and guidelines related to GCP.”

  • 2 “This course will improve my decision-making ability based on enhanced knowledge.”