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We are currently in the process of reviewing the CTA Scheme. More information at Review of Clinical Trial Approval Scheme.
All CTA scheme forms should be submitted to clinical.trials@health.gov.au (PDFs or word). Electronic/digital signatures can be used. If sending the forms by email (recommended), you are not required to send physical (hard-copy) copies to the mailing addresses detailed in each form.
Submission of the CTA application
The CTA application contains two parts: the application form and supporting data.
Application form
Before commencing the trial, the sponsor must submit the application form. This form provides details of the sponsor and the ‘unapproved’ goods proposed to be used in the trial (medicine, biological and/or medical device).
- 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)
Supporting data
The sponsor of the trial should submit supporting data in an electronic dossier (searchable PDFs). This should be sent via email to clinical.trials@health.gov.au - if the file is too large, please contact us for advice.
Commencement of the trial and addition of trial sites
The sponsor must notify the TGA within 28 days of commencing supply of the goods at each site for each new trial conducted under the CTA scheme as well as additional sites in ongoing CTA trials.
- 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)
Completion of a trial
The sponsor should notify the TGA of the completion of trials conducted under the CTA scheme after the trial has been completed at all sites. This would usually correspond with the last patient’s last visit. It is not necessary to notify completion dates for individual trial sites.
- CTA clinical trial completion advice form (pdf,96kb)
- CTA clinical trial completion advice form (docx,123kb)
More information