Good Clinical Practice (GCP) [2.0 RAC]

2.0 RAC Credits Online Course Online Course Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective Member: $255.00 Nonmember: $350.00

Good Clinical Practice (GCP) [2.0 RAC]

Member Price: $255.00
List Price: $350.00

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies involving human subjects.

This course identifies the regulations on the proper conduct of clinical research with human subjects that were put in place due to ethical issues in human research; explains the role of the informed consent process in protecting human subjects; and describes the roles and responsibilities of the clinical review team. In discussing the factors that led to the development of GCPs, the course will provide an understanding of GCPs’ overall goals.

Because GCPs are international guidelines, the cooperation and collaboration among the US Food and Drug Administration (FDA) and other regulatory agencies also will be explored.

At A Glance

  • Target Audience: This online course is designed for professionals in all areas of clinical research, including regulatory affairs, compliance, clinical operations, statistics and data management and quality assurance, as well as those in related departments.
  • Learning Level: Basic
  • Total Length of Course: 2 Hours
  • RAC Points: 2
  • Formats: Web and Tablet

Learning Objectives

Upon completion of this course, participants should be able to:

  • Discuss the purpose of Good Clinical Practice (GCP)
  • Summarize the history and development of GCPs
  • Explain the importance of informed consent to the clinical research process
  • Determine how GCPs affect different clinical development activities
  • Identify the similarities and differences between US Food and Drug Administration (FDA) regulations and International Conference on Harmonization (ICH) GCP guidelines
  • Outline the roles and responsibilities of sponsors, investigators, Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) and Independent Data-Monitoring Committees (IDMCs)

Lesson Titles

  • Lesson 1: Overview of Good Clinical Practices
  • Lesson 2: GCP in the Real World
  • Lesson 3: GCP Roles and Responsibilities
Enrollment Period: 6 months 
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