Most trials of unapproved products in Australia run under the Clinical Trial Notification (CTN) scheme, where an ethics committee reviews the trial and the sponsor notifies the TGA, rather than the TGA evaluating the data first. This guide walks through the sequence, the CTN versus CTA decision and what the sponsor keeps current. Not legal advice.
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Choose the scheme
CTN or CTA, with HREC input
Local sponsor in place
An Australian entity takes the sponsor role
HREC review and approval
Scientific and ethical review
Site governance authorisation
Institution approves each site
Sponsor submits the CTN
Online form and fee; the trial is notified
Recruit and report
Safety reporting and updates through the trial
The short answer
The scheme
Australia regulates the supply of therapeutic goods through the Therapeutic Goods Administration. A product that is not on the Australian Register of Therapeutic Goods cannot be supplied in a trial without an exemption, and the two schemes are the ways the regulation lets trials go ahead. In the CTN scheme, the TGA is notified of a trial and does not review the data. Safety and scientific responsibility is taken by the HREC and the institution, which is why HREC review in Australia is thorough and why many sponsors treat the process as fast but not light.
The result is that early-phase and many later-phase trials can start in a timeline set by ethics review and site governance, not by a regulator evaluation queue. That is a reason Australia is a popular location for first-in-human and early-phase studies, discussed in our overview of clinical trial software in Australia, which covers the country context, privacy law and tax incentives. This page goes deeper on the scheme workflow itself. Biologicals and some devices also use the scheme, so check the TGA information for your product type.
Which scheme
| CTN scheme | CTA scheme | |
|---|---|---|
| Who evaluates the trial | The HREC reviews; TGA is notified and does not evaluate trial data | TGA evaluates product information; HREC also reviews the trial |
| Sponsor action | Notify TGA online after HREC approval and governance authorisation, with the fee | Apply to TGA with the supporting data and fee; start after approval |
| When it is used | Most trials, including most Phase 1 to Phase 3 studies | Where a sponsor or HREC wants a TGA evaluation, or where the product risk profile calls for it |
| Time to start | Driven by HREC and site governance | Adds the TGA evaluation time |
| Changes after start | Updates through the sponsor to HREC and, where required, to the TGA; check the TGA guidance | Variations to the approval go to the TGA |
Do not treat this table as the rule. Discuss the choice with your HREC and read the TGA guidance for your product.
Workflow
Order and responsibilities as commonly described in TGA guidance and by state research offices. Forms, fees and portals change, so confirm with the TGA.
Confirm CTN eligibility, discuss the choice with the HREC, and make sure an Australian entity is the sponsor. Overseas companies commonly use a local CRO or subsidiary.
Draft the protocol, the investigator brochure where needed, the participant information and consent form, and the data protection description. The HREC reviews these.
The HREC reviews the scientific and ethical aspects against the National Statement and good clinical practice. National mutual acceptance of ethics review across participating states can reduce duplication in multi-site trials; check the current arrangements.
Each institution reviews feasibility, resources, contracts and indemnity, and authorises the trial at the site. Sites can run in parallel with ethics review in many institutions.
After HREC approval and governance authorisation, the sponsor submits the online notification to the TGA with the fee. The trial is notified when the form and the fee are in.
Release the approved study build, train the staff and recruit. Keep the notification current if sites or products change.
Safety reporting follows the national guidance on monitoring and reporting in trials involving therapeutic goods, with reports going to the HREC and, as required, the TGA. Amendments are reviewed by the HREC and notified onward as required.
Build the visits and forms from the protocol and test skip logic, edit checks, e-signatures and the audit trail in the free sandbox while HREC review is running.
Sponsor duties
The CTN is a point-in-time notification, but the responsibilities behind it continue. The HREC expects the sponsor to report serious breaches, safety signals and amendments, and the institution expects the trial to run as approved. The TGA guidance sets out what changes need to be updated against the notification, for example product changes, new sites and a change of sponsor, so check what applies and keep a log of notifications beside the HREC correspondence.
Good clinical practice applies in Australia, with the TGA adopting the ICH guideline with annotations, and the National Statement governs ethical conduct. Our ICH E6(R3) guide explains the current direction of GCP. Both HREC and monitors will look at the same things inspectors do: whether the study ran to the approved protocol, whether consent was properly obtained, whether data changes are traceable and whether adverse events were reported on time.
Participant data is subject to the Privacy Act 1988 and the Australian Privacy Principles, plus state and territory health records laws. HRECs and institutions often ask where data will be hosted and who can access it. Capture hosts in the EU (Frankfurt) or the USA (N. Virginia), chosen per study, and does not list an Australian hosting region. If your institution requires in-country hosting, raise it with the team at the start of evaluation. Read our note on vendor security questionnaires for the questions HRECs and governance offices ask.
Adverse event data needs to be complete, dated and attributable so that serious events can be reported within the required windows. Use structured forms with seriousness and causality fields, as described in our adverse event reporting software guide. Know in advance who reports to whom.
Checklist
CTN or CTA, with the reasoning and the HREC discussion filed.
Legal entity, contact and responsibilities set out in the CRO or sponsor agreement.
Approval letters and authorisations for each site on file before notification.
Notification record and any TGA acknowledgement filed; institutions that ask for the acknowledgement have it.
Approved forms only, with an audit trail of changes and a blank eCRF PDF for the file.
Version control for the participant information and consent form; signed copies retrievable.
Dry run of a serious adverse event from site entry to report, with named recipients.
Hosting region, roles with access, encryption and audit logging described for the governance office.
In Capture
Capture is a self-serve EDC with eCRF, ePRO, eConsent and safety workflows in one system with one audit trail. For a CTN trial the sponsor can show the HREC and the governance office the blank eCRF PDF, the approved form lifecycle, the role model and the audit trail, and can test everything in the free sandbox before going live. Capture does not file the CTN or connect to TGA systems.
Sites authorised
2 of 3
CTN
Pending
The Clinical Trial Notification scheme is a pathway in which a Human Research Ethics Committee reviews a trial of an unapproved therapeutic good, and the sponsor then notifies the TGA online. The TGA does not evaluate the trial data at notification.
Under CTN the HREC takes responsibility for the scientific and ethical review and the TGA is only notified. Under the Clinical Trial Approval scheme the sponsor applies to the TGA, which evaluates product information before the trial can start.
According to TGA guidance as reported in search results, once the online notification form is submitted and the fee is paid. Some HRECs and approving authorities may ask for the TGA acknowledgement before recruitment, so check locally.
The sponsor in Australia is expected to be a local legal entity, and overseas companies commonly use an Australian CRO or subsidiary to act as sponsor. Confirm the current requirement on the TGA website.
The fee is set by the TGA and changes over time. This guide gives no figure; check the TGA summary of fees and charges before you budget.
Yes. HREC approval and site governance authorisation come before the sponsor notifies the TGA, and both continue to apply through the trial.
Capture is a self-serve EDC platform with eCRF, ePRO and eConsent, hosted in the EU (Frankfurt) or the USA (N. Virginia). It does not list Australian hosting, so confirm that this fits your institution data location requirements.
No. It is orientation for sponsors and QA teams. Read the current TGA guidance, the National Statement and your institution requirements before you act.
Keep exploring
Clinical trial software in Australia
Country overview and privacy.
EDC for first-in-human studies
Early-phase data capture.
EDC for Phase 1 trials
Phase 1 specifics.
Adverse event reporting
Safety data capture.
ICH E6(R3) guide
Where GCP is heading.
Vendor security questionnaire
Governance office questions.
Informed consent
Short definition.
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