ATP-National Teletrial Supervision Plan
Use this template to create a teletrial supervision plan based on the study protocol.
ATP-National Teletrial Supervision Plan
Video: what is the role of the Teletrial Supervision plan?
This video will show you how stakeholder work together, using the nationally harmonised Teletrial Supervision Plan to deliver clinical trials closer to where patients live.
Video: What is the role of the Teletrial Supervision Plan
Video: A step-by-step guide to filling our the Teletrial Supervision plan
This is your guide to filling out the National Supervision Plan. It goes through the three main sections of the document; clinical trial details, protocol-specific activities and endorsement so that your teletrial runs safely and smoothly.
Video: A step-by-step guide to filling out the Teletrial Supervision Plan
Teletrial Supervision Plan: Information for Human Research Ethics Committees
This document provides the Human Research Ethics Committee (HREC) with a summary of a Supervision Plan.
Individual site-specific Supervision Plans are developed and submitted to relevant Research Governance Offices for each Satellite Site application. The use of this document is optional and may be edited according to jurisdictional preferences.
Teletrial Supervision Plan: Information for Human Research Ethics Committees
Teletrial Research Governance Review Checklist
Use this checklist to guide submission requirements for research governance review of a clinical trial to be conducted via the Teletrial model at your site.
Teletrial Research Governance Review Checklist
Medicines Australia Clinical Trial Research Agreements
The National Clinical Trial Agreement (NaCTA) Panel is comprised of representatives from all states and territories.
Together with Medicines Australia, the NaCTA panel have developed five Clinical Trial Research Agreements (CTRAs), that are available for use by any sponsor and/or institution for specific clinical trial scenarios.
Medicines Australia Clinical Trial Research Agreements
Teletrials Subcontract
This subcontract complements the Clinical Trial Research Agreement - Medicines Australia Standard Form, which forms the Head Agreement when a study is conducted under a Teletrials model.
The Subcontract is entered into between the Institution (as named in both the CTRA and the Subcontract) (also known as Primary Teletrials site) and the Subcontractor (that is, the Teletrials satellite site).
Medical Technology Association of Australia Clinical Investigation Research Agreements
The Medical Technology Associate of Australia (MTAA) has developed a suite of Clinical Investigation Research Agreements (CIRAs) for commercially sponsored studies of medical technology.
The agreements have been developed in cooperation with the National Clinical Trial Agreement (NaCTA) Panel comprising representatives from all states and territories.
Medical Technology Association of Australia Clinical Investigation Research Agreements
Medicines Australia Form of Indemnity for Clinical Trials - Standard
For use where the Indemnified Party is providing premises for the conduct of the Study and HREC Review, or is providing premises only.
Medicines Australia Form of Indemnity for Clinical Trials - Standard
Guidance for the use of optional teletrial wording to be inserted into Participant Information Sheet
This guide gives example optional wording for including on Teletrial Participant Information Sheets.
Optional Teletrial wording to be inserted into Participant Information Sheet
Teletrial Ethical Review Checklist
Use this checklist to guide submission requirements for the ethical review of a clinical trial to be conducted as a teletrial.
Teletrial Ethical Review Checklist
Stand Alone Teletrial Participant Information Sheet and Consent Form
This Stand Alone Teletrial PICF does not replace the clinical trial PICF.
Use this Stand Alone Teletrial PICF when converting an approved clinical trial to a Teletrial, so that an amendment to the approved clinical trial PICF is not required for the inclusion of details for the Australian Teletrial Program (ATP) (or other teletrials).
Stand Alone Teletrial Participant Information Sheet and Consent Form
Research Governance checklist
Use this checklist to guide submission requirements for research governance review of a clinical trial to be conducted via the Teletrial model at your site.
This checklist assumes standard submission requirements for research governance review of human research in Australia are applied and only provides advice on considerations relevant to submission requirements for RGO review of the Teletrial model.
Teletrial Research Governance Checklist
Clinical Trial Research Agreement for Investigator Initiated Teletrial
Use this template to document the agreement between the primary site and satellite site.
Stand Alone Teletrial Participant Information and Consent Form - Person Responsible/Medical treatment decision maker
Use this Stand Alone Teletrial PICF when converting an approved clinical trial to a teletrial, so that an amendment to the approved clinical trial PICF is not required for the inclusion of details for the Australian Teletrial Program (ATP) (or other teletrials).