Teletrials

Teletrials (also known as decentralised trials) are studies that use telehealth technology to allow communication between a larger centre (primary site) and a geographically separate centre (satellite site) to enable delivery of aspects of a clinical trial. Some examples of telehealth technology include videoconferencing (e.g. Zoom), telephone call and mobile health apps. This technology supports a Principal Investigator to supervise Associate Investigator/s to conduct a clinical trial at a Satellite Site.

The Principal Investigator remains responsible for the trial. A detailed Supervision Plan is required, in addition to a Delegation Log required by ICH GCP for all Satellite Sites regardless of experience. Trial participants may have trial visits at both the Primary and Satellite Sites, as determined by the Protocol and Supervision Plan.

A National Standard Operating Procedure has been published by the Australia Government to help organisations standardise their procedures for clinical trials and teletrials in Australia. These documents can be accessed here:

·         National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia

·         National Principles for Teletrials in Australia

Clinical Trial Research Agreements

The conduct of the teletrial should be governed by a Clinical Trial Research Agreement (CTRA) between the Sponsor and the Primary site, and is known as the ‘head agreement’. A sub-contract also required between the Primary Site and any Satellite Site Institutions. A copy of the CTRA templates are available on the Medicines Australia website here:

·         Clinical Trial Research Agreements

·         Clinical Trial Research Agreement – Tele Trials Subcontract (Primary and Satellite sites)

Please see the following link for further information on Clinical Trial Research Agreements: https://www.slhd.nsw.gov.au/concord/ethics/sponsors.html