Do you need to request Metro North to sponsor your clinical trial?
If you are a Metro North researcher intending to conduct a clinical trial of an unapproved device or medicine (including not approved for the specific cohort, or dose) sponsored by Metro North, you must seek approval by contacting Metro North Research before submitting your ethics application via MetroNorthResearch-ClinicalTrials@health.qld.gov.au
Submit additional governance documentation
All additional clinical trial documentation submitted for research governance review must be:
- listed on the Research Governance Cover letter
- uploaded with the SSA in ERM for research governance review
All documentation must include versions and dates that are consistent with the cover letter.
Additional governance requirements
Good Clinical Practice (GCP) Certificate
The Guideline for Good Clinical Practice (GCP) is an internationally accepted standard for designing, conducting, recording and reporting of clinical trials. GCP compliance is a condition of research governance approval for the conduct of a clinical trial in Metro North.
Metro North Site Principal Investigators (PI’s) must provide evidence a GCP certificate of completion for an accredited course undertaken within the previous 3 years.
Investigator’s Brochure (IB)
The HREC approved Investigator’s Brochure(s) (IB) must be submitted for research governance review. Where the HREC has approved multiple versions, only the current approved version is required.
Clinical Trial Notification (CTN)
Clinical trials that involve the use of ‘unapproved’ therapeutic goods, including use of an approved drug or device in a manner (dose or cohort) that is not ARTG approved, must register using the Clinical Trial Notification (CTN) scheme. The CTN Scheme is a notification process to the Therapeutic Goods Administration (TGA).
CTN process
The process for CTN approval involves both ethics and governance. The eCTN registration is completed online and uploaded with the HREA via ERM for HREC review. When the HREC approval letter is received, the eCTN can be lodged with the TGA. Once received, the CTN Acknowledgement letter must be submitted to the Metro North research governance office via ERM either with the SSA submission or as a post authorisation notification (PAN) depending on the status of the clinical trial approvals. Refer to the Clinical trial notification (CTN) form – user guide for more information.
CTN approving authority
Clinical trials that include a Metro North site must include the following Metro North Health approving authority details on the eCTN registration form.
Metro North Health approving authority (for studies to be conducted at Metro North)
| Approving authority | Metro North Hospital and Health Service |
| Name | Adjunct Professor Jackie Hanson |
| Position | Chief Executive, Metro North Health |
| Phone number | 07 3647 9550 |
| MetroNorthResearch-RGO@health.qld.gov.au |
Clinical Trial Agreement and Insurance
A clinical trial agreement is required for all clinical trials conducted at a Metro North site. Clinical trials that involve collaborators or parties external to Queensland Health must include specific reference to insurance and indemnity arrangements in the agreement and the certificates of currency must be submitted for research governance review.
Standard Form of Indemnity
Metro North research governance will only accept the Medicines Australia Form of Indemnity template.
The Name and address of the legal entity (indemnified party) is provided below for inclusion in the template:
Metro North Hospital and Health Service (ABN 18 496 277 942), Block 7 Level 14, Butterfield Street, Herston, Qld 4029, Australia
Teletrials
A teletrial is a clinical trial that is delivered closer to home, particularly for regional, rural and remote patients. It includes groups of clinical trials sites that work together under the supervision of Principal Investigator as the Primary Site. A cluster is a group of two or more sites conducting the same trial.
The Australian Teletrial Program aims to improve regional, rural and remote patient access and participation in clinical trials through proven teletrial models and digital communications to connect clinical trial sites. The Australian Teletrial Program provides a suite of teletrial resources for evaluating a trial site, study start-up checklists and essential teletrial documentation templates.
The National Teletrials Compendium supports a national approach to teletrials through the National Principles for Teletrials in Australia and the National Standard Operating Procedures for Clinical Trials, including Teletrials in Australia. Compliance with the compendium provides assurance to the public that clinical trials protect the rights, safety and wellbeing of participants and the data generated from clinical trials is credible.
Clinical trials registry
Under Section 19 of the Declaration of Helsinki (2008) “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.” In addition, the International Committee of Medical Journal Editors (ICMJE) has made an essential criterion for publication of a trial in one of their journals that the details of a trial should be publicly available in a clinical trials registry.
The clinical trial registration number must be recorded on the SSA application.
The two primary clinical trials registries are: