Wednesday, February 20
09:00 – 12:00
“Flipped” = Face-to-face (3hrs) + some online component (30 min).
$200 per person (*please note that some institutions are hosting and funding this w/shop for their staff).
Tanya Symons (Director, T Symons Associates PTY LTD)
Tanya has established her consultancy in Australia, working for both Commonwealth and State governments. She is using her knowledge of international best practice to influence the streamlining and standardisation of research-related processes in Australia and authored the 2016 Safety Monitoring and Reporting Guidelines and its three supporting guidelines for the NHMRC. She is the GCP training provider for numerous organisations across Australia.
The origins of GCP
Good Clinical Practice and the Regulatory Framework
The Conditions and Principles of GCP
Reporting and Archiving
Sponsor and Investigator Activities
Informed Consent and Study Records
Safety Reporting in Research
Anyone conducting human research. The session is primarily designed for those working on drug or medical device trials; either managing their own investigator-led trials or collaborating on externally sponsored multi-centre clinical trials. Investigators working on other interventional trials will also gain useful insights into the quality systems that apply.