The Office for Research Governance and Development (ORGD) has a risk-based monitoring program to:
- enhance the safety of patients and staff participating in clinical research
- protect human participants' rights and well-being and ensure that research data is high quality
- encourage transparency and provide research oversight
- promote good research practice
- mitigate institutional sponsorship risks or participation in investigator-initiated research studies and clinical trials.
All research projects conducted at Gold Coast Health (GCH) are screened and reviewed to determine on-site monitoring frequency and intensity.
On-site monitoring visits begin with a risk assessment and feasibility review. The research project will then be assigned a monitor plan to determine monitoring visit frequency and intensity. The Principal Investigator (PI) and the research team will be contacted by email and telephone to arrange the first meeting and subsequent monitoring visits.
Refer to the additional contacts page to contact us about our research monitoring.
The meeting reviews the research and its conduct surrounding:
- participants screening, eligibility and recruitment
- procedures for obtaining informed consenting
- randomisation processes
- safety reporting
- data verification
- protocol compliance and protocol deviation reporting
- trial master file/investigator site files – administrative documents, contracts, GCP essential documents
- investigational product storage and accountability
- tissue, blood sample, etc., storage and handling
- document storage, management, retention, and archiving
- operational management of the research project – staffing and resources
- research team training and communications
- financial review of compliance to grant-funding agreements, study billing and project expenditure.
Sponsors are required to submit their reports for monitoring visits to the GCH Office for Research Governance and Development.