Platforms

Clinical Research Facilitation

Our Clinical Research Facilitation Platform aims to support clinical research across the Monash Partners network by addressing barriers and systemic issues. Our priorities include:

  • 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
  • Coordinating workforce development programs that increase research capacity and foster a culture of research
  • Addressing barriers to research through harmonisation and streamlining of processes
  • Engaging externally to value add to Monash Partners activities.
Our Lead

Professor Nikolajs Zeps

An experienced clinical research administrator with expertise in research ethics, governance and regulatory affairs. He holds an adjunct professorial position with the Eastern Health Clinical School at Monash University. He is leading a number of initiatives aimed at facilitation of clinical research, and in particular clinical trials, in Victoria and Nationally.

Our Initiatives

Key initiatives of our clinical research facilitation platform include our Good Clinical Practice Training Program, the Australian Clinical Trials Education Centre (A-CTEC) and the Monash Partners Research Collaboration Agreement. We have also developed a research agreement guide to which agreement should be used and the type of indemnity required for each type of study.

Good Clinical Practice (GCP) in Clinical Trials

Good Clinical Practice

Australian Clinical Trials Education Centre (A-CTEC)

Research Ethics and Governance

Monash Partners Research Collaboration Agreement

Good Clinical Practice

A research collaboration agreement template has been pre-approved by all Monash Partners member organisations and can be used for investigator-initiated collaborative research projects, including projects involving two or more parties. This agreement is NOT SUITABLE for contract research for industry partners, clinical trials, registry projects.

No legal review is required and Monash Partners member organisations aim to grant approval in five business days or less, providing the following criteria are met:
• The agreement is completed as per the guidelines
• The agreement is completed correctly
• Legal terms are not modified except for amendments allowed by the guidelines.

Guidelines to assist in completing the agreement can be accessed, HERE.

The agreement template can be accessed, HERE.

Research Agreement Guide

Research Ethics and Governance

A number of regulatory documents are required when conducting research, including agreements, insurance and indemnities. Below is a guide to which agreement should be used and the type of indemnity required for each type of study. Links to the various agreements are provided after the table.

SPONSORSHIP ARRANGEMENT

TYPE OF STUDY

INSTITUTION OF ORIGIN

NAME OF AGREEMENT

TYPE OF INDEMNITY

Commercially-Sponsored or Collaborative Group

Clinical Trial or Interventional Study

Medicines Australia

(MA) 1,2

Standard CTRA

MA Standard Indemnity

and/or

MA HREC Review Only Indemnity

CTRA: Contract Research Organisation acting as the Local Sponsor

CTRA: Collaborative or Cooperative Research Group (CRG) Studies – Standard Form

MA Standard Indemnity

and/or

MA HREC Review Only Indemnity (may be provided)

CTRA: Phase 4 Clinical Trial (Medicines)

Medical Technology Association of Australia (MTAA)3

MTAA Australia Standard CIRA

MTAA Standard Indemnity

and/or

MTAA HREC Review Only Indemnity

Medicines Australia CTRA:

Contract Research Organisation acting as the Local Sponsor

Alfred Health4

Clinical Trial Preparation Agreement

Not required

Investigator-Initiated, Company Supported

Clinical Trial or Interventional Study

Alfred Health

Currently being considered by Medicines Australia4

Investigator-Initiated, Company Supported CTRA

Not required

Investigator-Initiated

Clinical Trial or Interventional Study

Medicines Australia1,2

CTRA: Collaborative or Cooperative Research Group (CRG) Studies

Non-Interventional Study

Download the Research Collaboration Agreement or

Material Transfer Agreement4

LNR Study

Alfred Health4

Research Collaboration Agreement or

Material Transfer Agreement4

1. Medicines Australia: Clinical Trials Research Agreements
2. Medicines Australia Indemnity and Compensation Guidelines
3. MTAA Clinical Investigation Research Agreements
4. Alfred Health Agreement Templates
5. Monash Partners

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