eProtocol

TGA Online CTN scheme

TGA – Online CTN Scheme

Please submit CTN submissions via the TGA Business Services website.

Studies under CTN

The Human Research Ethics Committee (HREC) reviews the scientific validity of the trial design, the balance of risk versus harm of the therapeutic good, the ethical acceptability of the trial process, and approves the trial protocol. The HREC is also responsible for monitoring the conduct of the trial.

The institution or organisation at which the trial will be conducted, referred to as the ‘Approving Authority’, gives the final approval for the conduct of the trial at the site, having due regard to advice from the HREC.

It is the responsibility of the sponsor to ensure that all relevant approvals are in place before supplying the ‘unapproved’ therapeutic goods in the clinical trial.

Studies under CTX

A sponsor applies to the TGA seeking approval to supply ‘unapproved’ therapeutic goods in a clinical trial. The TGA evaluate summary information about the product including relevant, but limited, scientific data (which may be preclinical and early clinical data) prior to the start of a trial.

After the TGA have completed their evaluation, the study must then be reviewed by a HREC. The outcome of the TGA’s review must be provided in the HREC application. The HREC is responsible for considering the scientific and ethical issues of the proposed trial protocol. Where a study is submitted under the CTN scheme, the HREC may decide that an application must go through the CTX scheme.

Bellberry HREC Contact Officer (the person who will receive correspondence for the HREC (if required) about this CTN):

Name: Trina O’Donnell
Position: Operations Manager, Bellberry Ltd
Contact Number: 08 8361 3222
Contact Email: bellberry@bellberry.com.au