Good Clinical Practice and Trial Regulation for Investigational Sites: A Refresher Session  

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 Therapeutic Goods Regulations (1990). It introduces the 
internationally recognised quality standards, ICH GCP and ISO 14155 and clarifies the roles and responsibilities of key players. The course content is illustrated using examples of common findings from 
GCP audits and regulatory inspections.
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Price: $110/person
Mode of delivery: Online, on demand narrated video course with supplementary learning resources
Description: A refresher/update session that enables delegates to build on their existing knowledge and to address gaps in their understanding of GCP requirements.  
Duration: Average 1.5 hours including completion of a quiz plus additional time reviewing resources relevant to the learner’s role.

Learning Objectives:
Learners will be able to: 
  • Understand the risk-based application of GCP principles aimed at fulfilling the key requirements for participant safety and trial reliability  
  • Describe the site’s responsibilities in the context of protocol and Australian ethics and regulatory framework to avoid common audit findings 
  • Understand the requirements for key trial processes such as safety reporting, informed consent and the reporting of non-compliance and serious breaches of GCP/protocol. 
  • Understand the importance of documentation and the need to generate high quality data

Certification: A certificate is generated on completion of a short quiz to consolidate knowledge.
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