GCP: An Introduction to Clinical Trial Preparation and Design
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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:Overview: This session briefly describes the relevant legal documents and guidelines relating to clinical trial design. Clinical trials in drug development: The crucial role of clinical trials in the drug development cycle is examined. Regulatory requirements and financial pressures, and their interaction with trial design, are discussed. Protocol design: This session provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed. Clinical trial preparation: This session provides an overview of the role of the sponsor in supporting and improving quality in the conduct of clinical trials. Endpoints: This session focuses on clinical trial endpoints. The purpose of endpoints and the types are discussed in this part. Statistical elements: This session covers the role of statistics in clinical trial design and analysis, as acknowledged in the International Conference on Harmonization (ICH) guideline for Good Clinical Practice (GCP). Study design: This session provides an overview of the main types of study design. Data capture and management: This session describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape. 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: Outline the role of clinical trial design in clinical research. Identify the relevant legal documents and guidelines relating to clinical trial design. Recognize the essential statistical components for clinical trial design and how these affect design choice. Define the general principles and concepts for trial design, and describe the implications of design choice on regulatory acceptance. Identify the strategies to improve data capture and management. Describe how electronic data capture can improve clinical trial development. | |
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