All research projects conducted at Gold Coast Health undergo monitoring and quality assurance using a risk-based approach.
Monitoring and quality assurance focuses on overseeing the progress of clinical research with a focus on the prevention and mitigation of risks to data quality and to processes that are critical to participant protection and study integrity. Monitoring and quality assurance is essential to ensure:
- The rights, wellbeing and safety of study participants are protected.
- Data captured as part of the study is secure, of high quality, accurate, complete and verifiable from source documents.
- The study is being conducted, recorded and reported in compliance with the current approved protocol/amendments and by approved personnel.
- Research misconduct and fraud are deterred, and inadequate research practices are identified before they escalate to research misconduct.
- Good Clinical Practice (GCP) is promoted and compliance with guidelines for research governance, including applicable regulatory requirements, is achieved.
Monitoring and quality assurance can begin at all phases of a research project, right from protocol design to publication. The Office for Research Governance and Development can assist your research team as the project is initiated and then monitor the conduct of the research as the study progresses. Any research project can be selected but generally higher risk research projects will be selected first.
Clinical Trials of an investigational medicinal product or an investigational medical device that are sponsored by Gold Coast Hospital and Health Service (GCHHS) under the Therapeutic Goods Administration Clinical Trial Notification Scheme will undergo Risk-Based Monitoring to ensure compliance with GCP and the Sponsor’s Quality Assurance and Quality Control processes.
Do you have a question regarding research monitoring? We hope that you find your answer in our FAQs.