Audits are one of the mechanisms used by the REGI Unit 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), state and federal legislation, regulations and guidelines, and applicable institutional polices.
An audit is a systematic and independent examination of research project activities to determine whether a research project is being conducted in accordance with applicable requirements. An audit may be scheduled periodically to confirm Protocol compliance and adherence to Good Clinical Practice (GCP) and regulatory requirements.
Research Project audits are educational activities aimed at improving research conduct and research quality.
Internal audit 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
- Human Research Ethics Committee (HREC) audits; and
- REGI Unit instigated audits
- Conducted by research sponsors and research regulators (TGA, FDA, OGTR, QandS, DJPR, DHHS)
Internal Barwon Health HREC and REGI 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 or with a targeted approach.
Internal audits may be targeted to one aspect of a research project across the organisation, such as training logs for all clinical trials, or a comprehensive audit of a specific project.
Barwon Health Internal Audits are conducted according to the Barwon Health Conducting an Audit SOP (coming soon)
Types of Internal Audits
A Self Audit Tool has been designed to help research personnel reflect on their research conduct and compliance with guidelines for responsible research conduct.
Relevant members of the study team should complete the Self Audit annually. The Self Audit should be submitted for all BH HREC projects and clinical trials, as an attachment to your Progress Report within ERM. It should also be retained as part of study files.
Desk Top Audit
Desk-top audits revolve around documentation only, and do not require face to face audit measures such as meetings, and study area visits. These may be conducted within the REGI Unit, reviewing existing research project documentation only, OR may also include a request from REGI to the PI to send additional project documentation for audit review.
Occasionally, a full audit of a research project is undertaken. This involves the Research Governance Officer visiting the space where the study is being conducted and examining all of the study files, source data, and observing procedures in detail, such as randomisation and consenting process. This type of audit may be spread over several sessions if necessary. Researchers will be informed if a full audit is to take place with at least 6 weeks notice.
What are some common Internal Audit findings?
- Non-compliance with privacy and confidentiality requirements
- Slow/Poor recruitment
- Incomplete training and role delegation documentation
- 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
What happens after an Internal Audit?
The REGI Unit 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 REGI Unit 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 REGI Unit will issue an Audit Certificate when all findings are resolved.
Last Modified: Thursday, 26 May 2022