Approvals & Registration

The Clinical Trials Notification (CTN) and Clinical Trials Exemption (CTA) schemes are how 'unapproved therapeutic goods' may be lawfully supplied for use solely for experimental purposes in humans.  

Your external Sponsor will know if your study needs a CTN or a CTA (not all studies do), and will be in charge of lodging the CTN/CTA with the TGA. Your responsibility at Melbourne Children’s is to make sure our site details are correct on the CTN/CTA form. Find more information about that here: Research Governance and Ethics: Multi site research.

For more in-depth information on this topic, see MCTC CTN & Trial Registration.

All research must have Ethics Approval from their Reviewing HREC, and Governance Authorisation from the RCH Governance Office (RCH REG) before it can commence. The Reviewing HREC does not have to be the RCH HREC, but it does have to be a registered HREC, under the purview of the NHMRC.  

Continuation of ethics approval and governance authorisation is subject to satisfactory progress reporting and other requirements from the Reviewing HREC and Local Governance Office. 

Find more information on Ethics and Governance Processes on the RCH Research Governance and Ethics page. 

Find more information on HRECs in general, and the list of registered HRECs on the NHMRC’s Human Research Ethics Committees page, and on the Vic Department of Health’s page HRECs, RGOs and Organisations.

For a visual summary, refer to the process maps shown below: 

·         MCTC043 Flowchart | Ethics & Governance Process for Stand Alone Sites

·         MCTC044 Flowchart | Ethics & governance Process for Lead and Accepting Sites

For more in-depth training on this topic, enrol in the Ethics Review Process online course.

As part of the process to obtain your Governance Authorisation at Melbourne Children’s, you will need to get signed Supporting Department Declarations from every campus department that will be involved in your study. These declarations outline what services are required of them as part of your study (as per your Protocol), and the additional funding or resources they require to perform this additional work.  

Find more information on this on the Research Governance and Ethics: Governance only – SSA.

If your study involves exposure to any ionising radiation, regardless of whether or not it is a part of routine clinical care, you must acquire a site-specific radiation safety report from a Medical Physicist for your study.  

Medical procedures that involve ionising radiation are: 

·        Radiology: e.g.: CT scans, X-rays, EOS images, fluoroscopy, angiography 

·        Cath lab: all procedures 

·        Nuclear medicine: all scans, including Positron Emission Tomography (PET) and Gated blood pool scans 

·        Endocrinology: DEXA scans 

·        Radiotherapy 

For more information on acquiring a radiation safety report at RCH or MCRI, see Research Governance and Ethics: Multi site research.