Introduction to Good Clinical Practice and Trial Regulation for Investigational Sites

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 per learner 
Mode of delivery: An online, on-demand, narrated video course with supplementary learning resources.  
Description: An introductory session for those new to GCP providing insights into the practical application of GCP illustrated with examples of common site audit and inspection findings.  
Duration: Average of 2 hours including a short quiz, plus additional time reviewing resources relevant to the learner’s role.

Learning Objectives:
Learners will be able to: 
  • Be aware of the factors influencing the regulatory framework for trials
  • Understand the site’s responsibilities in the context of protocol the ethical and regulatory framework  
  • Differentiate the roles and responsibilities of key players, including regulators, ethics committees and institutional governance offices 
  • Be aware of the key audit and inspection findings for trial sites 
  • Delineate the responsibilities of the investigational site and the sponsor and understanding the site’s responsibilities in the context of protocol and Australian ethics and regulatory framework to avoid common audit findings 
  • Be aware of safety reporting terminology and trial safety reporting requirements  
  • Be aware of all the key requirements relating to informed consent 
  • Better understand how to apply good documentation practices

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