Embedding GCP and clinical trial governance into routine clinical care – the challenges and solutions — ASN Events

Embedding GCP and clinical trial governance into routine clinical care – the challenges and solutions (#144)

Sophie Mepham 1
  1. Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia

Australia does not currently have a national program for training its clinical research staff in the principles of research or Good Clinical Practice. Countries such as the UK and the USA have invested heavily in research training for public hospital staff and Australia is challenged by increasing regulatory requirements to demonstrate appropriate training to conduct clinical trials safely. The challenges to many hospitals conducting research today include the ever increasing regulatory requirements, increasing in site sponsor audits, enhanced monitoring visits, longer and more complex monitoring letters and compliance with GCP in everyday clinical practice. This talk will discuss these challenges, but more importantly will focus on solutions emerging both nationally and internationally that will assist clinical trial staff to run studies safely and produce high quality data.

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