The purpose of this toolkit is to address the differences in practice that are required specifically for teletrials and are not intended to be a complete guide to the process of conducting a clinical trial in Australia.
The stages of a teletrial have been categorised from beginning to end in the menu on the left. Information resources are arranged by topic and follow the chronological sequence of trial set-up, conduct and close-out.
Click on each heading to view summaries of related topics and links to resources.
Education and training modules have been developed to guide researchers through each step of a teletrial to increase their understanding of how to incorporate telehealth into clinical trial design and conduct, and to support the implementation of the resources found within the toolkit.
The full suite of e-learning modules can be found directly at the VCCC Alliance Centre for Cancer Education, or linked underneath each step of a teletrial in the toolkit.
The National Statement on Ethical Conduct in Human Research (2007) - Updated 2018, sets national standards for use by any individual, institution or organisation conducting human research. This includes human research undertaken by governments, industry, private individuals, organisations, or networks of organisations.
In February 2022, all jurisdictions agreed to implement the Governance Framework in health service organisations as an embedded approach (as clinical research is core health service business) under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme.
All Australian sites are bound to abide by the Australian Code for the Responsible Conduct of Research. Adherence to the 2018 Code is a prerequisite for the receipt of funding by the National Health and Medical Research Council.
The Australian Clinical Trial Handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using 'unapproved' therapeutic goods. It assists trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) to understand their roles and responsibilities under the therapeutic goods legislation.
https://www.tga.gov.au/resources/resource/guidance/australian-clinical-trial-handbook