A two-year project to pilot the implementation of the Tele-Trial Model funded by a consortium of industry, research institutes and consumer groups with matched funding from MTPConnect commenced in August 2017 and has recently been extended for another year. The project is piloting the Model at sites within NSW, Victoria and Queensland while also supporting the implementation of the Model in other states.

The project is co-chaired by John Zalcberg and Sabe Sabesan and guided by a funding consortium and 4 advisory groups:

  • MA Industry Advisory Group
  • Cancer Cooperative Trial Group Advisory Group
  • Department of Health Advisory Group
  • Investigational Medicinal Product Advisory Group

The following resources have been developed to assist sponsors and sites to establish the Tele-Trial Model:

  • Introduction to the COSA Australasian Tele-Trial Model here
  • Tele-Trial Standard Operating Procedures (SOPs) here
  • Queensland Health Tele-Trial Subcontract here

The Australian ICH-GCP SOPs (including teletrials) and the Queensland Health Subcontract are currently under review for National Mutual Acceptance.

  • Supervision Plan Templates
    • Supervision Plan – Sites without Medical Specialist here
    • Supervision Plan – Sites with Medical Specialist here
    • Supervision Plan – Sites with Clinical Trials Experience here
  • Checklist to establish a Tele-Trial cluster for Sponsors and Sites here
  • Checklist of documents for RGO submission Primary and Satellite Sites here
  • Post approval steps – teletrial amendments for Sponsors and Sites here
  • Schedule 2 information for Subcontract June 2018 here
  • Primary Site Q&A Steps to establish the Tele-Trial Model here
  • Satellite Site Q&A Steps to establish the Tele-Trial Model here
  • Sponsor Q&A Steps to establish the Tele-Trial Model here
  • IMP Management in Teletrials here
  • Teletrials Primary Site IMP Handling SOP here
  • Remote consent process in Tele-Trials here
  • Sample PICF for Tele Trial Clusters here

The VCCC Teletrials Program has incorporated expertise from the Parkville Cancer Clinical Trials Unit (PCCTU) to develop a framework for Victorian institutions, applying the principles of the COSA Australasian Tele-trial Model and Queensland Health Standard Operating Procedures (SOPs). Links to Victorian specific SOPs including tele-trials, a tele-trials subcontract for Victoria and other resources developed by VCCC for tele-trials are available here

A nation-wide list of teletrial sites here