This podcast series explores the auditing and monitoring of clinical trials, to help you better understand the procedures and processes involved in delivering high-quality research.
Researchers and research operations and support staff wanting to learn more about key clinical trials processes.
This episode explores all things clinical trial audits: what they are, why they’re important, and how to prepare for one.
Episode host: Rebeka Freckleton, Manager Research Strategy and Partnerships at Northern Sydney Local Health District
Guests:
Rosemary Carroll, Clinical Nurse Consultant (Surgical Research) at John Hunter Hospital
Robert Kent, Research Operations Manager at the Kinghorn Cancer Centre
This episode delves into the how’s and whys of running a clinical trial monitoring system for investigator-initiated trials. It discusses the benefits and challenges of monitoring clinical trials as well as the three different models of monitoring implemented at their organisations.
Episode host: Sharon Lee, former Clinical Research Manager at Western Sydney Local Health District
Guests:
Katherine Bolton, Research Manager, Quality, Strategy and Improvement at Central Coast Local Health District
Sally Dean, Research Governance Coordinator at Newcastle Private Hospital
Kathryn (Kat) Hogan, Clinical Development Manager at GenesisCare
Below is a summary of the key policy and implementation documents related to monitoring clinical trials in
Australia
| Provider | Resource | Summary Information |
|---|---|---|
| Australian Commission on Safety and Quality in Healthcare | National Clinical Trials Governance Framework | See Actions 1.11 Incident management systems and open disclosure and 1.12 Suggested strategies to meet this action. |
| Australian Commission on Safety and Quality in Healthcare | Australian Hospital Patient Experience Question Set (AHPEQS) | The AHPEQS is a survey used by hospitals and healthcare services to ask recent patients about their experiences of treatment and care. |
| National Health and Medical Research Council | Safety monitoring and reporting in clinical trials involving therapeutic goods | The Guidance provides advice on how risk-based quality management may be applied in a non-commercial trial setting. It identifies commonly used monitoring techniques for both remote and on-site monitoring. |
| National Health and Medical Research Council | National Statement on Ethical Conduct in Human Research 2025 | The National Statement defines monitoring as the process of verifying that the conduct of research conforms to the approved proposal. Chapter 5.1. defines institutional responsibilities (research Governance). Institutions are responsible for human research they conduct this includes monitoring in accordance with the national statement. Chapter 5.4 addresses monitoring of approved research by institutions via their research governance arrangements. |
| Therapeutic Goods Administration | TGA Annotations to ICH Guideline for Good Clinical Practice | The TGA ICH GCP integrated addendum identifies responsibilities of the sponsor for trials involving therapeutic goods. It notes: The sponsor should implement a system to monitor quality throughout all stages of the trial process. Sponsors should use a risk-based approach to quality management and when identifying risks decide which should be reduced or accepted. |
| Therapeutic Goods Administration | Australian Clinical Trial Handbook | The handbook provides guidance on conducting clinical trials in Australia using ‘unapproved’ therapeutic goods. See the section on Trial sponsor responsibility of trial management and monitoring. |
| Australian Clinical Trials Education Centre (A-CTEC) and the Victorian Comprehensive Cancer Centre (VCCC) Alliance | Investigator Initiated Trials Toolkit Subsection: Monitoring | This resource provides an overview of monitoring including monitoring trial conduct and ensuring safety. It provides information on: -who is responsible -links to national guidelines different models of monitoring -what activities should be included when monitoring -documentation following the monitoring visit -managing non-compliance corrective and preventative actions |
| Victorian Comprehensive Cancer Centre (VCCC) Alliance | Different Ways to Monitor Clinical Trials | This document identifies: -The benefits of monitoring -What is source data verification monitoring -What should be monitored -Different types of monitoring -Top tips to choose the right monitoring strategy |
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