Australia

DCT Feasibility Assessment Australia The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This workbook provides an overview of the current and proposed regulatory landscape applicable in Australia in relation to Decentralized Clinical Trials (“DCTs”). Australia abides by the regulations set forth by the Therapeutic Goods Administration...

2.1 Name of Regulatory Authority Medicines and Medical Devices are regulated in Australia by the Therapeutic Goods Administration (TGA) .  https://www.tga.gov.au/ The TGA is a Commonwealth government department that sits under the feder...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. Applications to the HREC should be made electronically via this link .  The submission re...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant. The TGA administers two pathways for clinical trials, the Clinical Trials Notification (CTN) ...

5.1 Does local regulation require PI/CI to be approved/registered by any regulatory authority (e.g., RA/EC)? The Principal Investigator must be a registered practicing physician with adequate experience and skills in running a clinical trial. T...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. If you are exporting human body fluids, organs, and other tissues , you: do not need a TGA export permit if the volume of each individ...

7.1 eConsent/Remote Consent  At present, eConsent use is not widespread in Australian clinical trials, although some trialing of eConsent software is occurring in an ad-hoc manner. Whilst a number of sponsors, CROs, and a handful of sites ...

8.1 What data privacy and/or technology regulations need to be complied with in order to run a trial in the countries of interest? Data from clinical trials are governed mostly by the Privacy Act 1988 . See the relevant section below. Priva...

9.1  Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them (including the language/claims used and whether or not the mention of open-...

10.1 Clinical Trial with Investigational Medicinal Product 10.2 Pediatric Investigation Plan (PIP) Australia’s version of the Paediatric Investigation Plan (PIP) is the Paediatric Development Program.  TGA: The Paediatric de...

NHMRC (National Health and Medical Research Council) (2018) ‘Australian Code for the Responsible Conduct of Research’, NHMRC, Australian Government, https://www.nhmrc.gov.au/file/14384/download?token=gje4DNtT TGA (Therapeutic Goods Administratio...

Australian Code for the Responsible Conduct of Research Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods Membership profile form (DOCX 50 KB) (not available in pdf) ToR/SOP requirements form (DOCX 60 KB) (no...