Monitoring and quality

We’re committed to supporting high-quality research, even after Human Research Ethics Committee (HREC) approval. Our site monitoring program and quality management system helps researchers meet ethical requirements throughout the life of their study.

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
A commitment to continuous improvement
Maintaining HREC accreditation and certification

Ongoing oversight and site monitoring

Our 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 protect 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.

HREC Structure and Certification

Transparency and public accountability

To promote transparency and continual improvement, Bellberry publishes:

Listings of Waivers of Consent granted by our committees.
Information on the TGA CTN Scheme, explaining how our HRECs review clinical trials before notification to the TGA.

HREC Processes and Governance

Continuous improvement

We embrace 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 help us to remain at the forefront of best practice in human research ethics review.

This ensures that our service remains trusted, transparent and adaptive to the evolving research environment.

Useful links

Monitoring and quality

Quality management