
Monitoring and Quality
Bellberry is committed to supporting high standards of quality and compliance for all research reviewed by our HRECs. Through a proactive site monitoring program and quality management system, we support researchers and research sites to maintain alignment with ethical requirements following HREC approval.
Quality Management
Quality management underpins every aspect of Bellberry’s operations. Our quality framework focuses on continual improvement, compliance, and consistency across our HRECs and internal systems.
The Bellberry Quality Management System (QMS) incorporates:
- Documented policies, procedures, and work instructions
- Auditing of Bellberry HREC approved studies
- Auditing of internal process and procedures
- Continuous improvement
- Maintaining HREC accreditation and certification
Ongoing Oversight and Site Monitoring
Bellberry’s monitoring framework supports the conduct of approved research in accordance with the National Statement on Ethical Conduct in Human Research (2025) and Good Clinical Practice (GCP) standards.
Site monitoring helps maintain the integrity of research and the protection of participants by providing a mechanism for ongoing oversight after HREC approval has been granted. Monitoring may be conducted via desktop audits or in-person site audits.
Monitoring activities may include:
• Site visits for routine reviews of approved research.
• Review of investigator site files and documentation to ensure compliance.
• Verification that consent processes, reporting, and documentation remain consistent with approved protocols.
• Assessment of how serious adverse events, amendments, and deviations are managed and reported.
These activities are designed to be constructive and educational rather than punitive. Findings are discussed collaboratively with researchers and used to enhance quality and compliance across all studies.
Certification and accreditation
All Bellberry committees are NHMRC-certified under the National Approach to Single Ethical Review of Multi-Centre Research and are listed on the NHMRC website.
Bellberry also maintains AAHRPP accreditation, demonstrating international alignment with the highest research ethics and participant safety standards.
Transparency and continuous improvement
To promote transparency and public accountability, Bellberry publishes:
- Listings of Waivers of Consent granted by its committees.
- Information on the TGA CTN Scheme, explaining how our HRECs review clinical trials before notification to the TGA
Continuous Improvement
Bellberry embraces a culture of reflection and learning. Feedback from researchers, sponsors, and committee members is used to refine processes and policies. Regular review meetings, external benchmarking, and engagement with national and international ethics networks allows Bellberry to stay at the forefront of best practice in human research ethics review.
This commitment ensures that our service remains trusted, transparent, and adaptive to the evolving research environment.


