GCP: An Introduction to ICH Good Clinical Practice (ICH-GCP)
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Download 2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline:Harmonization: The topics covered in this session map the development of ICH and the processes involved in establishing international standards and the technical requirements to ensure the safety, quality and efficacy of new medicines. ICH GCP Guidelines: The topics covered in this session describe the principles and structure of ICH GCP and provide a broad context in which to apply the standards of good clinical practice. Teamwork: This session examines the roles of the sponsor, investigator and monitor and the communication and interaction necessary to fulfill these obligations and conduct a successful trial. Documentation: This session connects these key documents with the responsibilities of the investigator, sponsor, monitor and support team. Investigator responsibilities: This session covers the main responsibilities of the investigator for the conduct of the clinical trial and explains how to ensure the accuracy, completeness, legibility and timeliness of data generated during the study. Informed consent: This session focuses on the main requirements necessary to support an effective and efficient informed consent process. Monitor responsibilities: This session explores the responsibilities of the monitor and provides insight into these key challenges. Summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or consolidation of learning points. | Objectives:Students completing this course should be able to: Understand the processes involved in establishing international standards and technical requirements for Good Clinical Practice. Describe the principles and structure of ICH GCP. Apply the main guidelines of Good Clinical Practice in the workplace. Explain the key responsibilities of the Sponsor, Investigator, Monitor and the Study Team in conducting a successful clinical trial. Understand the use of key documentation used in clinical trials. Demonstrate an understanding of the informed consent process in clinical trials. | |
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