National One-Stop-Shop for clinical trials
On 2 May 2024, the Minister for Health and Aged Care announced an investment of $18.8 million to progress the National One Stop Shop for clinical trials and health research.
The National One Stop Shop will harmonise and nationalise the administration and regulation of health and medical research. The Department of Health and Aged Care will establish an easy-to-use website to help patients, researchers and industry find, conduct, participate and invest in high quality and ethical research in Australia.
As part of the National One Stop Shop, the CTN and CTA schemes, safety reporting, and the Good Clinical Practice Inspection Program will be incorporated into the national platform.
CTA scheme reforms
We are currently in the process of reviewing the CTA Scheme. More information can be found at Review of Clinical Trial Approval Scheme
Increased oversight of medical device clinical trials
The 2019 Action Plan for Medical Devices has led to major changes in our regulation of medical device clinical trials.
We have increased our ability to identify trials that pose a high-risk to patient safety and ensure the safety and wellbeing of medical device trial participants.
Update to medical device legislation and inclusion of the medical device clinical trials in the Good Clinical Practice Inspection Program (GCPIP)
Legislative changes strengthened our powers to:
- request information about the safety of devices used in trials under the CTN or CTA schemes.
- inspect medical device trial sites for compliance with Good Clinical Practice.
Two webinars were provided by the GCPIP team in May and June of 2024 to communicate the inclusion of medical devices within the GCPIP.
Update to the CTN form and CTN form user guide
On 4 April 2024, the CTN form and CTN form user guide were updated to:
- address issues in data quality,
- support more accurate and correct data collection,
- support the review of high-risk medical device clinical trials, and
- assist the scheduling of GCPIP inspections.
A webinar was provided by the TGA on 14 March 2024 to communicate the updates to the CTN form and first-in-human high-risk implantable or cardiac invasive medical device clinical trials.
Good Clinical Practice Inspection Program (GCPIP) reforms
Publishing guidance and metric reports to communicate learnings of the GCPIP
Our GCP inspections commenced in July 2022. To support the introduction of the GCPIP, we published guidance and delivered three webinars in 2022.
In July 2023, we published the first annual metrics report on the GCPIP risk-based routine GCP inspections carried out between 1 July 2022 to 31 December 2022. We also delivered two webinars about the metrics report and sharing insights from the inspection program.
Developing education resources to improve GCP compliance
We are developing e-learning modules to assist stakeholder’s understanding of the compliance requirements for clinical trials regulated under the CTN and CTA schemes.
Safety reporting of Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs)
In November 2023, a new safety reporting form for SSI/USM was published on our website. Sponsors must notify us of SSIs and USMs using the form by sending to clinical.trials@health.gov.au
Suspected unexpected serious adverse reactions (SUSAR) and unanticipated serious adverse device effects (USADE) continue to be reported to Adverse Event Management System (AEMS) and Medical Device Incident Reporting System, respectively.