Monitoring is designed to ensure the safety and well-being of human participants and it is critical to the conduct of high-quality studies.
All research projects conducted at Gold Coast Health undergo monitoring and quality assurance using a risk-based approach.
Gold Coast Hospital and Hospital Service (GCHHS) has Research Monitors within the Office for Research Governance and Development implementing Risk-Based Monitoring. These roles perform monitoring of behalf of GCHHS when clinical trials are sponsored. All research activity and clinical trials can be monitored.
Monitoring can be defined as the act of overseeing the progress of clinical research and of ensuring that it is conducted, recorded, and reported in accordance with the study protocol, Standard operating procedures (SOP), Good Clinical Practice (GCP) and the applicable regulatory requirements.
Monitoring is designed to detect, correct and prevent potential or existing problems. Participation in the monitoring program is aimed at sharing best research practice and improving compliance with the approved protocol,
• National Statement on Ethical Conduct in Human Research 2007 (updated 2018),
• Australian Code for the Responsible Conduct of Research, 2018 (the 2018 Code),
• Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2),
• ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice,
• Risk based management and monitoring of Clinical Trials involving Therapeutic Goods
During a monitoring visit, a research monitor will come and visit the research team in their clinical area and spend around half a day reviewing the project documents and the data. A member of the research team should be available to answer questions. At the end there will be a time to discuss findings and recommendations.