The National Teletrials Compendium, a significant deliverable from the Clinical Trials Project Reference Group, has now been released.
The National Teletrials Compendium supports a national approach to teletrials and consists of:
The Teletrials Compendium is consistent with the National Statement on Ethical Conduct in Human Research 2007 (Updated 2018), and also aligns with the Clinical Trials Governance Framework which has been designed to support the delivery and integration of high-quality clinical trials service provision into routine hospital care for improved patient outcomes. These National Principles for Teletrials are also consistent with recommendations from the Clinical Oncology Society of Australia’s (COSA) Australasian Teletrial Model – A National Guide to Implementation, September 2016.
The National Principles for Teletrials and the standard operating procedures have been developed to assist organisations engaged in conducting trials in Australia to, wherever possible, standardise their procedures for key operations related to clinical trials and specifically teletrials. They have been endorsed by all states and territories, together with the Therapeutic Goods Administration (TGA) and the National Health and Medical Research (NHMRC) through the CTPRG.
Compliance with the Teletrials Compendium provides public assurance that the rights, safety and well-being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data generated from the clinical trials are credible.
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