B1 – Update of National Initiatives to Improve the Clinical Research Landscape

This session will look at both national and jurisdictional initiatives that are improving the performance of clinical trials in Australia.

 

The Commonwealth will provide a (1) Brief overview of the clinical trials environment including the role of the Clinical Trial Jurisdictional Working Group and the Framework for Action (2) Provide an update on progress over the last year on key projects (3) Outline the importance of leadership and collaboration to maintain the momentum of improvements.

 

Following this, NHMRC will provide an update on:(1) streamlining clinical trial site assessment and  authorisation processes; (2)  Progress on developing a mechanism for recognising sites that are ready, willing and able to conduct clinical trials-CT Ready;Development of the human research ethics application (4) Other relevant projects.

The session will conclude with a presentation from TGA on the transition to the new online CTN system which aims to provide an update on future enhancements including (1) the latest developments in the CTN transition process (2) facts and figures about the transition and (3) How to stay in touch about the changes. The session will also provide information on regulatory and legal requirements of the clinical trial schemes.