Auditing Research Projects
The NHMRC National Statement on Ethical Conduct in Human Research (2025) requires institutions to monitor research projects to ensure they are conducted in compliance with the ethics approval provided.
Internal audit of research projects is an important means by which Western Health ensures research conducted under its auspices is conducted in accordance with good clinical practice (GCP) and approved ethical guidelines.
The Office for Research conducts three types of audit:
- Self-audit: completed by the research team using a WH Self Audit form every year along with the Annual Progress report (APR)
- Desktop audit: a remote review of project documentation by the Office for Research
- On-site audit: an in-person review conducted at the research site
All projects undertaken at Western Health - including Quality Assurance (QA), Low Risk, and Governance projects may be subject to audit.
Annual self audits
An annual self-audit must be completed for all approved research projects conducted at Western Health.
The Principal Investigator is responsible for completing and submitting both the Annual Progress Report and the Self-Audit Form to maintain ongoing ethics and governance approval for the project.
Any reminder emails issued by the Office for Research are provided as a courtesy only. Responsibility for ensuring timely submission of progress reports and self-audits remains solely with the research team.
Failure to submit a satisfactory Annual Progress Report and Self-Audit may result in the project being subject to a desktop or on-site audit.
Exception: Projects approved through the QA/MRR review pathway are not required to complete annual self-audits. Instead, a self-audit must be completed at the conclusion of the project and submitted together with the Final Report Form.
Desktop audit
Desktop audits may be requested by the Office for Research where an Annual Progress Report or Self-Audit Form has not been submitted, or where the information provided is considered incomplete or unsatisfactory.
The Principal Investigator (PI) will be notified when a desktop audit is required and will be provided with instructions regarding the documentation to be submitted to the Office for Research.
A desktop audit may include, but is not limited to, the following:
- Submission of a completed Annual Progress Report and Self-Audit Form, if not previously provided;
- A detailed review of selected study documentation as requested by the Office for Research, such as the study protocol, original ethics application and approval documentation, and post-approval submissions;
- Provision of electronic copies of relevant study documents for review.
Where desktop audit documentation is not provided within the requested timeframe, is deemed unsatisfactory, or where significant compliance concerns are identified, the Office for Research may initiate an onsite audit.
Onsite audits
Research Governance Auditors from the Office for Research will conduct periodic onsite audits of a range of research projects, including Site-Specific Assessment (SSA), Low-Risk (LR) Research projects, and Quality Assurance (QA) projects.
The purpose of these audits is to assess compliance with applicable requirements and may include:
- Review of all relevant study documentation;
- Assessment of compliance with Good Clinical Practice (GCP) principles;
- Verification of measures in place to protect participant privacy and confidentiality;
- Evaluation of data management, storage, and security practices.
Project documentation will be reviewed within the researcher’s department. The Principal Investigator (PI) is expected to attend both the opening and closing audit meetings. Prior to the audit, the PI will be contacted to arrange a mutually convenient time and will be provided with the Audit Review Rubric to assist with audit preparation.
Selection of projects for onsite audit
Projects may be selected for an on-site audit for either for-cause or no-cause reasons.
For-cause
A project may be selected for audit:
- At the request of the Human Research Ethics Committee (HREC);
- Following a protocol deviation or violation or a study breach;
- Following an adverse event site notification;
- Following a significant change in the project's risk classification;
- In response to a complaint or concern;
- Where annual Progress Reports have not been submitted as required;
- Where a satisfactory self-audit or short audit response has not been provided.
No-cause
Projects may also be selected on a random basis as part of the Office for Research's quality assurance and compliance monitoring activities.
Scope of audit
The audit scope may include a review of all project-related documentation and processes to assess compliance with applicable Western Health policies, procedures, guidelines, standard operating procedures (SOPs), regulatory requirements, and relevant national legislation including: