Project monitoring

Audits are one of the mechanisms used by the Research Development Unit (RDU) to ensure research projects under the auspices of Barwon Health are conducted in accordance with the NHMRC National Statement on Ethical Conduct in Research, the Australian Code for Responsible Research Conduct, Good Clinical Practice (GCP), the National Clinical Trial Governance Framework, state and federal legislation, regulations and guidelines, and applicable institutional policies.

An audit is a systematic and independent examination of research project activities to determine whether a research project is being conducted in accordance with the conditions of HREC approval and governance requirements. An audit may be scheduled periodically to confirm protocol compliance and adherence to GCP and regulatory requirements.

Research project audits are educational activities aimed at improving research conduct and research quality. Internal audits of research projects ensure;

• Reliability and integrity of information/data
• Compliance with legislation and guidelines
• Adherence to study protocol
• Protection of participants

Audits conducted at Barwon Health

Internal Audits

• Human Research Ethics Committee (HREC) audits
• RDU instigated audits
• Adrian Costa Clinical Trial Centre Quality Manager instigated audits

External Audits

• Conducted by research sponsors and research regulators (TGA, FDA, OGTR, QandS, DJPR, DHHS)

Internal Barwon Health HREC and RDU Audits

Research Ethics Officers or Research Governance Officers regularly conduct audits of research projects overseen by Barwon Health HREC and the Institution.

Projects are selected for audit either randomly, as per risk register and reporting patterns, or as requested by research departments, Research Directorate or Executive.  

Internal audits may be targeted to one aspect of a research project, such as training logs, across the organisation or may involve a comprehensive audit of a specific project.  

Barwon Health internal audits are conducted according to the Barwon Health Conducting an Audit Procedure (currently under review).

Categories of Audits

 

What are some common Internal Audit findings?

• No significant deviation from study protocol
• Non-compliance with privacy and confidentiality requirements
• Incomplete training and role delegation documentation
• Inappropriate research team member conducting consent and eligibility (drug trials require medical clinician)
• Inadequate notification of research participation in participants medical record
• Inconsistencies with consent form completion
• Changes to research methodology and recruitment process without seeking ethics approval
• Data management issues
• Unapproved recruitment advertisements

What happens after an Internal Audit?

The RDU will provide the Principal Investigator with an audit report following completion of an audit. This may occur within a meeting.

Principal Investigators will be notified in writing of any critical findings/risks that require immediate action within 1-2 days of completion of an audit.

The RDU provide guidance on appropriate responses to audit report findings, including CAPAs (Corrective and Preventative Action Plans). Critical findings may require the auditor to facilitate a Root Cause Analysis with the research team and the Quality and Safety Unit. 

Principal Investigators will be required to provide responses and CAPAs within 28 calendar days of receipt of the audit report.

Outstanding audit report responses and CAPAs, as well as unresolved findings, may lead to project suspension.

The RDU will issue an Audit Certificate when all findings are resolved.