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).

  • Teletrials Toolkit

    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).

  • HREC links

    University of Melbourne

    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

    Melbourne Health

    Monash Health

    Royal Children's Hospital

    Austin Health

    For a full list of HRECs, visit: https://www.nhmrc.gov.au/research-policy/ethics/human-research-ethics-committees

  • Good Clinical Practice

    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:

    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.

    MACH/AHRA members can complete this online training at a reduced cost. Each participant from the eligible organisation will now pay $40 (instead of $120) to gain access to this course. Access to the discounted GCP course can be gained by selecting “AHRA members” as the primary workplace when registering.

  • Australian Clinical Trials Education Centre (A-CTEC)

    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/

Clinical Trial Coordinators  Network Meeting 28th July 2022


Johannah Planche (MDHS Clinical Trials Contracts Officer)

Ash Hepburn (Legal & Risk - Insurance Lead)

Clinical Trial Coordinators  Network Meeting 12th April 2022


Michelle Iddles (MACH Manager)

Victoria McMorran (Office of Research & Ethics Integrity Clinical Trials Governance Officer)

Johannah Planche (MDHS Clinical Trials Contracts Officer)

Katie Ozdowska (MISCH Clinical Trials Officer)