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Introduction to Good Clinical Practice Training
This online GCP training course will review the evolution of current Good Clinical Practice guidance and regulation. It will review the responsibilities of the Sponsor, Ethics committee and Investigator as they relate to implementing Good Clinical Practice (GCP) with particular attention to the informed consent of study participants, adverse events and the trial master file.
This course meets the criteria for ICH E6 GCP training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Training materials include an audio-visual presentation with a competency assessment to confirm learning of key points. A printable course certificate is available upon completion of the course. Registration gives you immediate access to all online course materials for 30 days.
Key Topics
History of Good Clinical Practice
Responsibilities of the Sponsor, Investigator and Ethics Committee
Informed Consent
Adverse Events
Trial Master File
Who will benefit from this course
Senior Management
Clinical Operations
Medical Affairs
Regulatory Affairs
Quality Assurance
Course Contents
Two audio-visual presentations each followed by a self-paced competency assessment. Course completion survey and printable training certificate.
Instructor
Brett Vengroff
About Online Training
ComplianceLogix provides GCP training, GLP training and cGMP training, Six Sigma training and related compliance training courses. Enjoy the benefits of a secure, real-time multimedia learning experience with no travel required. The resources you need are already at your fingertips - all you need is an internet connection. Learn information critical to your business needs, when you need it.