Clinical Trials
MISCH is able to support all stages of development and progress of a clinical trial, from planning to execution and reporting. There are also many resources available to inform these stages, some of which can be found below. Keep up to date with clinical trial news and developments across the University and join the Clinical Trials Network.
Contact: katie.ozdowska@unimelb.edu.au to join the mailing list.
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All researchers should have policies, processes and procedures that govern the conduct of research via their respective premises. All researchers should familiarise themselves with the obligations and responsibilities that attach to them as researchers when initiating any research project. For links please review the research governance and ethics page.
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If you plan to conduct a clinical trial with the University of Melbourne as a sponsor, there are a range of resources to support you.
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Clinical Trials .gov is a US site listing clinical trials in the US and in other countries, including Australia.
The Australian New Zealand Clinical Trials Registry is an online public registry of clinical trials being undertaken in Australia. The Registry is part of the worldwide initiative to make public all clinical trials being conducted in order to improve transparency, avoid duplication, improve trial quality, promote collaboration and facilitate trial participation. Ethics committees require prospective registration as a requirement of ethical approval.
Clinical Trials Initiatives: This website provides a combined update on all clinical trials initiatives currently underway in Australia. It is an excellent resource for Australian research guidelines and regulations and Australian Government departments and agencies.
Competencies for Australian Academic Clinical Trialists: The Competencies are designed to support the training of staff involved in the conduct and oversight of clinical trials.
Safety monitoring and reporting in clinical trials involving therapeutic goods: The NHMRC developed these guidelines to address the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products and investigational medical devices for trials conducted under the Clinical Trial Approval (CTA) or Clinical Trial Notification (CTN) schemes.
Clinical Trials Alliance: Provides support and communication for Australian Clinical Trials.
Clinical research at the University of Melbourne: for internal researchers
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A suite of resources to support researchers conducting investigator-initiated trials developed by the MACH with the Victorian Comprehensive Cancer Centre (links to the VCCC website).
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Adaptable resources developed by the VCCC provide guidance to implement legislation, regulations, and guidelines for conducting clinical research through teletrials (links to the VCCC website).
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The University of Melbourne runs Human Ethics Drop-In Sessions, these sessions are open to all staff and students and are run each month on a Thursday for one hour. These scheduled sessions allow staff and students to discuss their human ethics application via Zoom and receive appropriate one-on-one advice on a first come, first served basis.
Visit: https://go.unimelb.edu.au/x7is
For a full list of HRECs, visit: https://www.nhmrc.gov.au/research-policy/ethics/human-research-ethics-committees
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Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Comprising 13 core principles, compliance with GCP is mandatory for anyone involved in the conduct or oversight of clinical trials and all key trial personnel must have a valid GCP certificate.
GCP training registered with TransCelerate BioPharma, Inc, which is certified to meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training, based on ICH E6 R2 can be accessed at via an online course provided by A-CTEC. This course is free but does require you to have an account with A-CTEC. This course was designed by the Clinical Research Development Office (CRDO) at Murdoch Children's Research Institute and is also TransCelerate-recognised and tailored to the Australian regulatory environment:
Visit A-CTEC: Good Clinical Practice = Good Research Practice to enrol (free).
Visit A-CTEC: New Account Sign-up to set up an A-CTEC account (free).
Please note: The A-CTEC GCP Course is not Victoria nor paediatric research specific. It is recommended that all researchers new to the Melbourne Children’s Campus attend the free CRDO workshop where possible:
All workshops are free for all Melbourne Children's staff and students. Melbourne Children's includes anyone who is an employee/student/honorary of the Murdoch Children's Research Institute, the University Of Melbourne Department Of Paediatrics, or The Royal Children's Hospital. The cost of the workshops for external participants (i.e. those who are not affiliated with Melbourne Children's) is $350 per workshop. This certificate is valid for 3 years.
Online training; the certificate is valid for 2 years.
Online training; the certificate is valid for 2 years.
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A-CTEC is a not-for-profit, Victorian developed, Australia-wide education centre, with a dedicated Learning Management System (LMS) hosting a suite of evidence-based, interactive clinical trials education opportunities suitable for a range of learning needs.
All staff involved in clinical trials in health service settings across Australia, regardless of role or site. The audience will include: study coordinators, research nurses and clinical trial assistants, investigators, clinical trial pharmacists, HREC and governance officers, clinical and non-clinical research staff, general staff in departments that interact with clinical trials, employees involved in clinical trials from hospitals, community health settings, universities, and any location where clinical trial research is undertaken.
To sign up and access the clinical trial educational resources visit: https://actec.myopenlms.net/
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Health Studies Australian National Data Asset (HeSANDA)
Enabling researchers to access and share data from health studies
The Health Studies Australian National Data Asset (HeSANDA) is a national program that makes health and medical research data easier to find. It facilitates access, sharing and reuse of research data, resulting in a reduction in research waste, improvements in researcher collaboration, and an opportunity to answer new research questions. It aims to support more efficient and effective research to help improve health outcomes. The research community across Australia has been working together through HeSANDA to develop Health Data Australia, a catalogue for health and medical researchers to register a description of their research so it’s easy to discover. A federated structure of partners across Australia then links researchers and facilitates data sharing and data access. This is possible through the searchable online catalogue and a secure access request portal. Importantly, the researchers who created the data always maintain control over their data and determine with whom it is shared.
Learn more about HeSANDA
https://ardc.edu.au/case-study/hesanda-case-study/
If you are affiliated with a MACH partner organisation contribute your trial to the MACH node catalogue here
If you are affiliated with a MACH partner organisation contribute your trial to the MACH node catalogue here
Visit the health Data Australia catalogue
https://researchdata.edu.au/health
For questions contact the MACH HeSANDA node directly
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The METIS Database is a searchable repository of guidance, procedures, and templates to help you conduct your research in accordance with Melbourne Children’s, State, National and international legislation and regulatory requirements. These resources have been predominantly developed and compiled by the Clinical Research Development Office (CRDO) and Melbourne Clinical Trials Centre (MCTC) and more recently, with input from the Melbourne Children’s Clinical Trial SOP Working Group. Here you will be able to find all current versions of supporting documents for use in clinical trials and other human research-related activities:
Clinical Trial Network Recordings
Access past clinical trial network recordings and view the presenter slides.