Clinical Research Facilitation

Overview

The purpose of the Monash Partners Clinical Research Facilitation Platform is to support clinical research by:

  • Leveraging the scale and breadth of our research and thematic structure to create communities of practice
  • Encouraging collaboration and sharing of research interests, learnings, best practice, and development of new research questions
  • Coordinating workforce development programs that increase research capacity and foster a culture of research within our network
  • Addressing barriers to research through harmonisation and streamlining of processes, innovative clinical research models
  • Coordinating access to clinical research support (e.g. Data Managers, Biostatisticians, Health Economics) across our network
  • Providing a facilitation and liaison service across the partners for external stakeholders (i.e. industry/Pharma/CROs/Commercial funders/Govt.)
  • Engaging externally to value add to Monash Partners activities.
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Our Priorities

Priority activities include:

  • Establishing Monash Partners and AHRA clinical research advisory committees
  • An industry engagement forum (please click here to register your interest)
  • Progressing a streamlined Ethics and Governance process
  • Coordinating streamlined consistent interpretation of NHMRC Safety reporting guidelines
  • Facilitating innovative trial engagement models
  • Establishing a Monash Partners Research support hub

Project Lead

An objective of Monash Partners is to be inclusive in all of our activities. If you would like to contribute an idea to help us facilitate research solutions across our partnership please send us an email.

The Clinical Research Facilitation Platform has a dedicated Project Lead, Mr Kurian Thomas.

Our Initiatives

Monash Partners continues to facilitate the needs of its members now and into the future. Some initiatives are one-off projects, for example, the streamlining of ethics approval processes. Other initiatives like our Good Clinical Practice training program are ongoing.  Soon we will be expanding our Clinical Research Facilitation initiatives to include priorities as identified. 

Good Clinical Practice Training

Monash Partners is pleased to offer free TransCelerate-accredited training in Good Clinical Practice (GCP) to all paid employees of its partner organisations.

Find out more

Research Ethics and Governance

A multi organisational working group, chaired by Professor Paul Myles, has been identifying the areas that are major barriers to research.

Find out more

Streamlining Project – Research Ethics and Governance

Overview

Health researchers across Monash Partners are able to start their projects more efficiently, thanks to a working group set up to streamline the cumbersome ethics and governance approvals process. The multi organisational Monash Partners’ Ethics and Governance working group chair Professor Paul Myles explains.

Historically, it could take a researcher many, many months to undertake the approvals process, mostly because of a lack of standardisation of forms and processes across health services. 

A working group has been meeting regularly to address this issue across the Monash Partners organisations. Applications are still subject to the same rigorous approval criteria, however, streamlining has reduced complexity and improved timeframes.

Cross Partnership Working Group


Professor Paul Myles is Chair of the Academic Board of Anaesthesia and Perioperative Medicine, and director of Anaesthesia and Perioperative Medicine at The Alfred. He holds a Master degree in Public Health (MPH), a doctorate (MD) degree in cardiothoracic anaesthesia, a Doctor of Science (DSc), and is an Australian National Health and Medical Research Council (NHRMC) Practitioner Fellow.

Below is a list of the Monash Partners Research Ethics and Governance Working Group:

  • Professor Paul Myles (Chair)
  • Mr Simon Barrett
  • Dr Andrew Carey
  • Ms Lee-Anne Clavarino
  • Ms Deborah Dell
  • Associate Professor Rose French
  • Ms Angela Henjak

  • Dr Souheir Houssami
  • Professor Alison Hutchinson
  • Ms Janet Russell
  • Ms Anne Spence
  • Professor David Taylor
  • Professor Nik Zeps.

Our Achievements

  • A requirement for all researchers to be trained in Good Clinical Research Practice (GCP)
  • Standard national ethics forms (HREA, not institution-specific Ethics and Governance forms), enabling researchers to use the same documents to seek Ethics approval and Governance authorisation for multi-site projects
  • Standardisation of other governance forms and approval across each of the MP sites
    • Site Specific Authorisation addendum (local governance)
    • Standardised Clinical Trials Agreement (CTA) and Research Collaboration Agreement (RCA)
    • Acceptance of electronic sign offs for agreements to shorten start-up time
  • A co-enrolment policy has been provided to MP sites
  • A list of MP clinician-researchers who are willing to contribute to a DSMC or “drug trial safety officer” role for investigator-initiated trials
  • Progress has been made to jointly evaluate a single electronic Ethics and Governance system platform for Monash Partners
  • Currently evaluating various models for Mutual Acceptance of ethics approval across MP sites.

You will find relevant Forms and Resources, here.