This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining ongoing compliance will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for their clinical studies.
The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development - Webinar by GlobalCompliancePanel
29 September 2010, United States
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Online Training Webinar
Online Training Webinar, United States
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GlobalCompliancePanel
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