eProtocol

Policies, SOPs, Guidelines

Please click on the links below to access the Bellberry Policies to be complied with for conducting research under Bellberry ethics approval.

Please note that these policies are for personal use only and not for distribution.


Standard Operating Procedures


Guidance

TGA – Online CTN Scheme
www.tga.gov.au

Studies under CTN

From 1 July 2015 the Clinical Trials Notification (CTN) Scheme transitioned from a paper based form to an online format. The paper-based notification form is now no longer available as there are some differences in the required information for the online form.

As a reminder any paper based forms the TGA receive after 1st July 2015 will need to be submitted online via the TGA Business Services website.

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 submits an application to the HREC seeking approval to supply ‘unapproved’ therapeutic goods in a clinical trial. We 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.

The HREC is responsible for considering the scientific and ethical issues of the proposed trial protocol.

The sponsor must notify us of each trial conducted using the unapproved therapeutic good(s) approved in the CTX application.

Bellberry HREC Contact Officer:
The person who will receive correspondence from us 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


Policies


Please contact the Bellberry Office if you have any queries regarding these documents.