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Barwon Health / Research

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Introduction to Clinical Trial Research

The purpose of this page is to provide information, resources and tools to introduce you to clinical trial research and support you through the process of conducting clinical trial research.

1. Overview of Clinical Trial Research Process


The Clinical Trial Process can be divided into the following stages:

  1. Feasibility
  2. Start-up
  3. Conduct
  4. Close-out


2. Commercially Sponsored vs Investigator Initiated Clinical Trials 

Commercially Sponsored

Investigator Initiated Clinical Trials

It is initiated by a pharmaceutical/device company or other commercial entity and not by an investigator at an insured Victorian public health service.

A pharmaceutical/device company is not acting as the Sponsor for the purposes of the CTN Scheme application.

The Trial is conducted to investigate a drug/ device for commercial development by its manufacturer/sponsor.

A pharmaceutical/device company is not directly funding the conduct of the study, that is, making payment to the relevant hospital or investigator.

The protocol has been developed and is the responsibility of a pharmaceutical/device company or other commercial entity.

The clinical trial addresses relevant clinical questions and not industry needs.


The Principal Investigator or the Hospital/ Institution is the primary author and custodian of the clinical trial protocol.

Other Considerations

There will be investigator initiated trials which will have some industry funding or industry contributions. Such funding arrangements must be declared in the protocol submission to ensure that the clinical trial retains its “investigator initiated” status.

Clinical trials that are initiated by co-operative/ collaborative research groups are treated as investigator initiated, provided they meet the requirements for co-operative studies.

Reference: VMIA Guidelines for Clinical Trials for Victorian Public Hospitals 2009

MACH and the VCCC Alliance have developed a suite of resources to support the conduct of Investigator Initiated Trials that can be accessed here.


3. New Starter Checklist

The New Starter Checklist has been developed to support the on boarding of new staff or those transitioning into a role in Clinical Research at Barwon Health. The checklist is provided to support your progress and will be used to record your competency in your new role. The checklist is in word format to allow you, your manager or coach to modify information for trial or protocol specific training.

Download the Barwon Health Clinical Researcher new starter checklist template here.


4. Clinical Trial Research Training

There are several elements of training that may be required for your role in Clinical Trial Research. These are summarised below.


Last Modified: Monday, 26 June 2023