Online CourseOnline Course Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective

Good Clinical Practice (GCP) [2.0 RAC]

2.0 RAC Credits Member: $255.00 Nonmember: $350.00
Good Clinical Practice (GCP) [2.0 RAC]

Description

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


Enrollment Period: 12 months
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