Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
This course identifies the regulations for how clinical research with human subjects should be conducted, which 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 what led to the need for GCPs, the course will provide an understanding of the overall goals of GCPs. Because GCPs are international guidelines, the cooperation and collaboration between the US Food and Drug Administration (FDA) and other regulatory agencies will be explored.
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)
Target Audience
This online course is designed for professionals in regulatory affairs, compliance, clinical operations and quality assurance, as well as those in related departments.