Research process resources: Approvals
“Important note: All documents can be found on the METIS Database. You can search using the document code or key words in title.”
Murdoch Children's Research Institute sponsorship
Investigator-initiated clinical trials (i.e. initiated and organised by an individual rather than an external collaborative network, company or organisation) need to request the Murdoch Children's Research Institute act as the legal representative for a trial, acting as the Sponsor.
Murdoch Children's Research Institute resources
Standard Operating Procedure (SOP) | Institutional Sponsorship for Sponsor-Investigator Initiated Trials (PDF)
Sponsorship Application form and Risk Matrix (downloadable word doc)- Certificate of Sponsorship and Investigator Responsibilities (PDF)
- Sponsorship Committee Annual Progress Report form (PDF)
Clinical trial registration and Clinical Trial Notification (CTN)
Clinical Research Development Office (CRDO) resources
Clinical trials that use an unapproved therapeutic good or use an approved therapeutic outside the conditions of its registration must submit a CTN notifying the TGA.
Trials require evidence of CTN submission prior to receiving Royal Children's Hospital (RCH) governance approval. We recommend you begin your CTN draft when you submit your study for ethics approval.
Please submit the Clinical Trials Notification request form if you need to organise a CTN. You should anticipate a minimum of 2-3 weeks for your CTN to be fully processed.
To make CTN variations, please submit the eCTN Variation submission form. A CTN variation is necessary for any changes to the study such as change in PI, change in expected trial completion dates, new sites added, additional medications or changes to drug administration etc.
A CTN is required as a part of your Governance Submission regulatory documents. Regulatory documents refer to those necessary for reporting the conduct of drug and device trials to the government. For more information, see below.
Ethics and governance
All research conducted on or by the Melbourne Children's campus must be approved by a Human Research Ethics Committee (HREC) before it can commence. Projects are also reviewed by the Melbourne Children's Campus Research Governance Manager to ensure compliance with National and local regulations and policies. Ongoing ethics approval and governance authorisation for projects are subject to satisfactory progress reporting and other requirements.
Melbourne Children’s resources
The Royal Children's Hospital Governance and regulatory documents, Research Ethics and Governance (REG) page provides comprehensive information on all aspects. For a visual summary, refer to the process maps shown below:
- Process map | Ethics and Governance - Stand Alone Site (PDF)
- Process map | Ethics and Governance - Lead and Accepting Sites (PDF)
Clinical Research Development Office (CRDO) workshops
Other resources
- Monitoring and Reporting Matrix - Reporting requirements for multi-centre trials
- Applicant User guide to the Ethical Review Manager (ERM)
- National/International Guidance and Policies | Ethics and Research Conduct