A clinical trial is a form of human research designed to find out the effects of an intervention, including a treatment or diagnostic procedure. A clinical trial can involve testing, eg a drug, a device, a surgical or other therapeutic procedure, a preventative procedure or a diagnostic procedure. The Sydney Local Health District HREC – CRGH is certified under the National Mutual Acceptance scheme to review all phases of clinical trials (phase 0. I, II, III and IV).
A clinical trial must have a sponsor ie the company, institution, organisation or individual that takes overall responsibility for the conduct of the trial and usually initiates, organises and supports the clinical trial. A sponsor may be an Australian commercial entity such as a pharmaceutical company or a not-for-profit organisation external to NSW Health such as a collaborative research group or university. For investigator-initiated clinical trials, the Local Health District may agree to act as the sponsor.
Each clinical trial conducted in a NSW Public Health Organisation and sponsored by an entity external to that organisation, must be governed by a Clinical Trial Research Agreement (CTRA).
Standard Medicines Australia Clinical Trial Research Agreements can be found here.
Standard Medical Technology Association of Australia (MTAA) Clinical Trial Research Agreements for device trials can be found here.
The commercial sponsor of a clinical trial must provide executed indemnities in favour of the Public Health Organisation at which the research will be conducted. In addition it should provide executed indemnities for the lead HREC reviewing the trial. Evidence of appropriate insurance should also be supplied.
Medical Technology Association of Australia (MTAA) Forms of Indemnity for device trials (Standard) can be found here.
For information on documentation required to be submitted to the Ethics Committee click here.
When is a CTN required?
A trial of any medicine or device (or its software) not entered on the Australian Register of Therapeutic Goods (ARTG) including any new formulation of an existing product or any new route of administration must be conducted under the CTN Scheme.
On 1 July 2015, the Therapeutic Goods Administration (TGA) launched the electronic clinical trial notification (CTN) scheme (Notification of Intent to Supply Unapproved Therapeutic Goods under the Clinical Trial Notification Scheme), which replaced the paper-based notification form.
All CTNs must be submitted using the online form. Guidance is available on the TGA website.
It is the responsibility of the clinical trial Sponsor to complete and lodge the CTN via the TGA Business Services (TBS) website.
External sponsors should not submit an online CTN until written HREC approval has been received.
External sponsors should add each site to the online CTN’s “trial site details” only after receiving written site authorisation.
A copy of the TGA acknowledgement of receipt of a CTN should be sent to the CRGH Research Office as soon as it is available, for inclusion on the study file.
Investigator initiated clinical trials (no external sponsor):
All procedures involving ionising radiation should be listed in the protocol.
Research protocols should follow the guidelines set out by the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) in its “Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes 2005” – Radiation Protection Series No. 8. Section 2.1 of the Code outlines the responsibilities of researchers.
The Code applies to research involving humans who are exposed to radiation which is additional to that received as part of their normal clinical management. The applicant must provide the HREC with an independent assessment or verification by a medical physicist of: (a) the total effective dose and relevant organ doses for those radiological procedures that are performed specifically for the research protocol and which are additional to those received as a part of the research participant’s normal clinical management; (b) whether these will exceed the ARPANSA dose constraints and (c) the risks associated with the radiation exposure.
The applicant must comply with any recommendations made by the Medical Physicist for risk wording in the Participant Information Sheet.
If applying to the CRGH Radiation Safety Officer, a Radiation Safety report form is available here
A checklist for proposals involving genetic sampling can be found here
In July 2016 the NSW Office for Health & Medical Research (OHMR) introduced a requirement for all NSW Local Health Districts (LHDs) to provide data for clinical trial metrics. These metrics will be utilised to measure the success of reform initiatives introduced by OHMR to improve trial approval and enrolment processes, and to improve NSW’s ability to competitively initiate and deliver health and medical research, including clinical trials.
The data collection process is facilitated and managed through the Concord Hospital Research Office. For commercially-sponsored trials only, investigators will be asked to provide data for two metrics:
Metric 5 - Date first participant is enrolled to the clinical trial. If this date is more than 40 days after site authorisation, a reason for lack of enrolment will need to be provided. This data will be collected for all commercially sponsored clinical trials where an SSA authorisation has been issued on or after 01/07/2016.
Metric 6 - Total number of participants enrolled over the life of a clinical trial at Study Closure (ie when study is closed to enrolment/recruitment at the site). If the total number of participants enrolled to the trial is less than the minimum enrolment target for the site (as specified in the CTRA), a reason for not reaching target will need to be provided. This data will be collected for all commercially sponsored clinical trials closed to enrolment at the site on or after 01/07/2016.
More information about the NSW Metrics for Health and Medical Research, including Clinical Trials can be found here.