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Good Clinical Practice and Trial Regulations for Investigational Sites: A Refresher Session (LIVE)

Course Outline
GCP is the framework that enables sponsors and investigational sites to conduct clinical trials in a manner that protects the rights, safety and well-being of participants, and supports the quality and reliability of trial data. This TransCelerate-approved course for site staff provides delegates with an informal but intensive overview of GCP and the regulatory requirements for trials. It introduces the internationally recognised quality standards ICH GCP and ISO 14155, clarifies key activities and summarises the roles and responsibilities of key stakeholders. 

Description: A course for those with prior GCP training
Price: $1600 + GST per session for up to 30 attendees
Mode of delivery: Live, interactive Zoom or Teams session
Duration: 1.5 hours training + 30 minutes post course reading and quiz

Learning Objectives
• Understand the regulatory framework for trials
• Be aware of the key audit and inspection findings for trial sites relating to the principles of GCP
• Differentiate the roles and responsibilities of key players
• Be aware of safety reporting and serious breach terminology and reporting requirements
• Build knowledge on topics such as informed consent and apply good documentation practices

: Certificate provided on course completion
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