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11 Nov 2019
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Integrating regulatory requirements and producing efficiencies

  • Victorian Comprehensive Cancer Centre

Harmonisation of trial management across metro and regional Victorian clinical sites enables process streamlining, improves collaboration and efficiencies, and removes bottlenecks.

Working with Cancer Trials Australia (CTA), the Victorian Comprehensive Cancer Centre (VCCC) has appointed two dedicated project officers to implement SiteDocs, an electronic document management platform, as well as facilitate training and support.

Sixteen clinical trial sites in Melbourne and regional Victoria are involved in the implementation which will enable our collective impact and produce greater efficiencies.

Saving the trees! Reducing printing

The implementation of an electronic document management platform aims to create regulatory documentation efficiencies and improved documentation collaboration to internal stakeholders and external sponsors.

The Austin Health Cancer Clinical Trial Centre is one of the VCCC member organisations benefiting from the program. Anne-Marie Woods is the centre manager, and says, “We partnered with SiteDocs in 2016 to streamline the management of core documents, which has been a very beneficial shift.

“More recently we are in the process, through the VCCC Building Capacity Through Efficiency Program, of adding ethics study-specific documents onto SiteDocs, which is again reducing the filed hardcopy documents.”

Changing from a manual, hardcopy process to an online, electronic process is not without difficulties, Anne-Marie has sought to mitigate risks and issues with oversight and an engaged team. “Our implementation of SiteDocs has been purposely measured, to establish engagement by staff including confidence that set-up and naming conventions are uniform and provide an internal process that is maintained to allow coordinators and the leadership team clear oversight of what has been uploaded into SiteDocs for each trial; to ensure we are always audit ready.”

Gaining collective knowledge and learnings for next steps

Gabriella Martello is one of the CTA project officers contributing to the SiteDocs implementation; travelling across Melbourne and to the regional clinical trial sites.

Anne-Marie said Gabriella’s assistance and guidance has been invaluable, “We have explored, along with Gabriella, different applications and approaches, tapping into her first-hand working knowledge of other site setups, which has been so beneficial and appreciated. She is such a great asset to the success of this VCCC program.”

The Austin Health Cancer Clinical Trial Centre aims to finalise and evaluate each stage of the SiteDocs implementation gaining information along the way.

Anne-Marie said, “The collective knowledge and learnings of numerous sites concurrently moving to SiteDocs is helpful as we consider what applications we want to implement. Consistency for sponsors and research organisations, for obtaining core documents, is certainly beneficial.”