Clinical trials in Hunter New England

The Hunter New England LHD CTSC advises the Hunter New England Human Research Ethics Committee (HNE HREC) on aspects of methodology and pharmacology for applications to conduct clinical trials and innovative therapy in Hunter New England LHD.

Learn more about the CTSC's membership and governance.

HNE HREC and CTSC meeting dates

2024

• 14 February
• 13 March
• 10 April
• 8 May
• 12 June
• 10 July
• 14 August
• 11 September
• 9 October
• 13 November
• 11 December

To authorise the Site-Specific Assessment (SSA), it must meet the CTMS minimum data set and be entered into the CTMS. 

Learn more about the minimum data set on the CTMS SharePoint site.

Note:

• The CTMS can take place at any time in the study start-up process. It is recommended that trial sites start early, during feasibility or the Human Research Ethics Commission (HREC) submission. At this time, 90 per cent of the study's minimum data set can be entered into the CTMS in preparation to begin the study.
• All Hunter New England LHD Principal Investigators for clinical trials must make sure the relevant team members have completed their CTMS training and competency assessment to access the CTMS.
• Researchers must prove they have used the CTMS as part of the SSA process in REGIS by uploading a screenshot of the study details page and the CTMS Study CCID number (located in the top-left corner of the study on the CTMS page).

For more information about the SSA/CTMS compliance process email HNELHD-ResearchOffice@health.nsw.gov.au

The NSW Health policy directive on the fee schedule for research ethics and governance review of clinical trial research sets out the mandatory ethics and governance fees to be charged for processing research applications NSW Public Health Organisations (PHOs).

Fees are charged for commercial and non-commercial clinical trials with an external sponsor. 

Fees are not charged for non-standard contract reviews for Investigator Initiated clinical trials, as per the fees schedule.

Researchers must fill out an invoicing authorisation form for all new clinical trial ethics and site applications and amendments with an external sponsor

Refer to the NSW Health policy directive for key definitions and guidance on application of fees and the fees schedule for the relevant clinical trial fees.

For further information, relevant forms or templates, contact the Hunter New England LHD Research Office at (02) 4921 4140 or email HNELHD-ResearchOffice@health.nsw.gov.au 

Learn more about safety reporting requirements for clinical trials in Hunter New England.

The CTRA is a regulatory document and must be provided when planning and/or preparing to conduct clinical trials in Hunter New England LHD. 

Go to the regulatory documents section to learn more about CTRAs and making a submission.

The Australian clinical trial sponsor must notify their intent to sponsor a clinical trial involving an unapproved therapeutic good. 

This must take place before starting to use the goods. The CTN notification form must be submitted and accompanied by the relevant fee.

From 1 July 2015, the Therapeutic Goods Administration (TGA) transitioned to an online system for Clinical Trial Notification (CTN) submission.

A trial of any medicine or device (or its software) must be conducted under the CTN Scheme if it is not entered on the Australian Register of Therapeutic Goods (ARTG). 

This includes any new formulation of an existing product or any new route of administration. 

The clinical trial sponsor is responsible for completing and lodging a CTN application form on the TGA Business Services (TBS) website. 

For further information, relevant forms or templates, contact the Hunter New England LHD Research Office at (02) 4921 4140 or email HNELHD-ResearchOffice@health.nsw.gov.au 

Note:

• External sponsors should not submit an online CTN without receiving written HREC approval.
• External sponsors must add each site to the online CTN’s 'trial site details' section only after receiving written site authorisation.
• A copy of the CTN's TGA acknowledgement of receipt must be uploaded with the site amendment application on REGIS for Hunter New England LHD Research Office acknowledgement before recruitment starts onsite.

Hunter New England LHD CTN application process

• A Hunter New England LHD CTN application form must be submitted along with the initial Site-Specific Application in REGIS.
• After submitting the CTN application, an invoice will be forwarded to the Principal Investigator for payment.
• If payment is not made, the application will become void and may cause a TGA breach.

CTN variations

Any changes or variations will require the Principal Investigator to submit a CTN variation to the TGA with details of the changes.

A fee will be charged for the following variations:

• Addition of new site(s) to a previously notified trial.
• Addition of a new therapeutic good to a previously notified trial.
• Change to previously notified therapeutic goods that creates separate and distinct goods.

Follow the same application process to submit variations for Hunter New England LHD sponsored trials. 

For further information, relevant forms or templates, contact the Hunter New England LHD Research Office at (02) 4921 4140 or email HNELHD-ResearchOffice@health.nsw.gov.au 

If your variation is urgent, email the Hunter New England LHD Research Office.

HNE HREC reviewed clinical trials

The following information should be used to support the registration of clinical trials that have been reviewed by the Hunter New England Human Research Ethics Committee (HNE HREC).

Clinical trials conducted in Hunter New England LHD facilities

The following information should be used to support the registration of clinical trials being conducted in Hunter New England LHD facilities.

Clinical trials conducted in our facilities with Hunter New England LHD as the study sponsor

The following information should be used to help identify the situations where Hunter New England LHD should act as a study sponsor. 

Hunter New England LHD should act as a sponsor where:

• the organisation coordinating the trial is based overseas, for example, the Children's Oncology Group trials.
• an investigator-led study within NSW Health needs Hunter New England LHD to act as the study sponsor on their behalf. 
• where a Hunter New England LHD staff member is the investigator but cannot take on the role of sponsor (e.g. if a clinical trial agreement is required because a pharmaceutical company is providing the trial medication and is requesting access to the study data in return). 

The Hunter New England LHD Research Office will lodge a CTN to the TGA for all Hunter New England LHD Investigator initiated projects and sponsored trials. 

The GCP is an internationally accepted standard for designing, conducting, recording, and reporting of clinical trials.

Health staff engaged in clinical trials must have GCP certification. It helps make sure staff conducting clinical trials meet international best practice standards.

The GCP is also required for accreditation under the National Clinical Trials Governance Framework.

Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the Therapeutic Goods Administration's GCP Inspection program.

Note: Hunter New England LHD staff should upload evidence of their GCP certification with their Site-Specific Application and Site Amendment submissions.

The Rural, Regional and Remote (R3) clinical trial enabling program is supported by funding from the Australian Government under the Medical Research Future Fund.

The program will deliver increased and more equitable access to clinical trials for patients in rural, regional, and remote NSW and ACT.