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.
Policies and Procedures
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.
Clinical Trials at the University of Melbourne
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.
Essential Tools for Researchers
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
Investigator-Initiated Trials Toolkit
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).
Adaptable resources developed by the VCCC providing guidance assist with implementing legislation, regulations, and guidelines for conducting clinical research through teletrials (links to the VCCC website).
MISCH collaboration agreement
Upon receiving a researcher request via our online portal, MISCH will contact you to organise a time to discuss your project; this initial discussion which entails (up to) a 1 and 1/2 hour meeting is free.
After the meeting, where you and the team agree further work will continue on the project, there is a collaboration agreement to be completed. This is a non-legally binding agreement that seeks to clarify the scope, intent and work to be conducted within the project; with the aim for transparency and clear communication.
- HREC links