CTA applications are submitted using paper-based forms. There are two forms that must be completed by the sponsor and sent to us via clinical.trials@health.gov.au
Part 1: The application
Part 1 is the formal CTA application. It must be completed by the sponsor of the trial and submitted to us with data for evaluation. The appropriate fee must be paid.
The CTA application form can be emailed to us. Supporting data for the CTA application should be provided in electronic format. It is preferable for data to be sent on USB or CD-ROM via post.
- Supply of unapproved therapeutic goods under the clinical trial approval (CTA) scheme - Part 1 The CTA application (pdf,124kb)
- Supply of unapproved therapeutic goods under the clinical trial approval (CTA) scheme - Part 1 The CTA application (docx,134kb)
Part 2: Notification of the conduct of a trial under the CTA scheme
Part 2 is used to notify us of the commencement of each new trial conducted as per the usage guidelines approved in the CTA application. There is no fee for notification of trials under the CTA scheme.
- Supply of unapproved therapeutic goods under the clinical trial approval (CTA) scheme - Part 2 Notification of the conduct of a trial under the CTA scheme (pdf,149kb)
- Supply of unapproved therapeutic goods under the clinical trial approval (CTA) scheme - Part 2 Notification of the conduct of a trial under the CTA scheme (docx,135kb)
The evaluation of a CTA application includes consideration of the manufacturing and quality and safety data in conjunction with the trial's usage guidelines, to inform a risk-benefit decision by TGA on whether or not to approve the clinical trial. Any significant changes to the information provided in support of the trial are considered a ‘variation’ and need to be approved as they have the potential to affect the initial decision to approve a trial.
We advise clinical trial sponsors to contact us via clinical.trials@health.gov.au if they intend to vary a previously approved CTA application.
CTA clinical trial completion advice form
The CTA clinical trial completion form is to notify us of the completion of trials conducted under the CTA scheme.
On completion the form can be emailed to us at clinical.trials@health.gov.au.
- CTA clinical trial completion advice form (pdf,96kb)
- CTA clinical trial completion advice form (docx,123kb)
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