Good Clinical Practice (GCP)
The Good Clinical Practice (GCP) Guideline 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. Compliance with the standard outlined in The Guideline for Good Clinical Practice, E6(R2) helps to ensure the rights and safety of clinical trial participants are protected, while maintaining high standards for data integrity and reliability of results.
This course identifies the resources, guidelines, guidance documents, and regulations associated with the proper conduct of clinical research with human subjects. Regulations surrounding maintenance of quality in conduct of human research were put in place due to ethical issues arising in in human research. This course will explain the purpose of the informed consent process in protecting human subjects and describes the roles and responsibilities of the research teams which are conducting the clinical trials. In discussing the historical events which led to the development of The GCP Guideline, the course will provide an understanding of The GCP Guideline overall goals.
Because The GCP Guideline is an internationally agreed upon and accepted standard, 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 working in all areas of clinical research, including regulatory affairs, compliance, clinical operations, statistics, data management and quality assurance, as well as those functioning in administrative or financial capacity.
- Learning Level: Basic
- Total Length of Course: 2 Hours
- RAC Points: 2
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:- Discuss the purpose of ICH Good Clinical Practice (GCP) Guideline
- Summarize the history and development of GCP Guidelines
- Explain the importance of informed consent in the clinical research process
- Determine how GCP Guidelines affect different clinical development activities
- Identify the roles and function of the US Food and Drug Administration (FDA) regulations and International Council on Harmonisation (ICH) GCP Guideline
- 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
This course is also included in:
