Sessions offered in 2019 will include:
This course provides investigators and other trial staff with an informal but intensive overview of the fundamentals of Good Clinical Practice. It introduces the internationally recognised version of this quality standard, ICH GCP, and clarifies the roles and responsibilities of key players. The course also aims to prepare researchers for the audit or inspection of their research projects; whether they are managing their own investigator-led trials or collaborating in multi-centre trials. Click here for more information. Information specific to ICH-GCP sessions for clinicans can be found here.
NHMRC Safety Reporting and Supplementary Guidelines: A Question and Answer Session
The session will summarise the key content of all four documents with particular focus on the Safety Monitoring and Reporting and Serious Breach Guidelines as these have raised a number of change management issues. The key aim of the session is to help delegates better understand how these guidelines should be operationalized at site and sponsor level. Click here for more information.
Consent and Ethical Considerations
Informed consent is at the heart of ethical research and this session explores processes and practices that can help ensure that valid, legal consent is achieved and maintained throughout the trial cycle. Click here for more information.