Risk Based Monitoring
La Trobe University has implemented a Risk Based Monitoring (RBM) framework to ensure all research conducted under the auspices of La Trobe University is conducted in accordance with the relevant regulatory codes, legislation and guidelines and is compliant with the approvals provided.
All human research, animal and biosafety projects undertaken at La Trobe University may be subjected to collaborative and supportive onsite and/or desktop audits.
A framework for monitoring research projects across the University is a requirement set by the University Council and will provide a useful snapshot of compliance across the University.
If you have any queries relating to the Risk Based Monitoring framework, please contact the team via the following:
How projects are selected for audit?
The criteria for selection for onsite and/or desktop monitoring includes (but is not limited to) the following:
- At the request of the Human Research Ethics Committee, Animal Ethics Committee or the Institutional Biosafety Committee following for example, a serious breach or a significant change in the classification of risk;
- Clinical trial projects where La Trobe is the sponsor, or those registered with the TGA via the CTN or CTA schemes;
- A history of significant unexpected adverse events and/or non-compliance events and/or complaints;
- Significant conflict(s) of interest declared (financial interest, contract research, etc.);
- Discrepancies in annual progress reports/insufficient annual progress milestone reporting; and
- Random selection (no cause).
Who will conduct the audit?
Monitoring will be conducted by representatives of the Ethics, Integrity and Biosafety (EIB) team and members of the relevant committee as required, i.e., for AEC approved projects as per s2.3.23 of the Australian code for the care and use of animals for scientific purposes (2013); and may include one or more of the following, on a case-by-case basis:
- Pre-monitoring review of research records.
- In person visits or Zoom meetings as appropriate.
- For-cause visits, to review any unanticipated issues.
- Close out visits to discuss findings and recommendations, where applicable.
The Ethics, Integrity and Biosafety team will notify Principal Investigators by email that their project has been selected for either an on-site and/or desktop audit and to identify a mutually convenient time for the audit. The notification will identify the project number, type of audit, and provide audit guidance including a check list to assist preparation.
Principal Investigators are required to maintain documentation that creates a transparent audit trail providing a description of the research steps taken from the commencement of the research project to the development and reporting of findings.
Principal Investigators will be provided with audit report findings including any Corrective and Preventative Actions Plans (CAPAs) in a timely manner and given appropriate time to address the report. EIB will issue an Audit Approval when all findings have been resolved.
The monitoring of all research provides not only an opportunity to recognise and adopt best practice and researcher accountability but is also an educational platform aimed at raising awareness of the requirements to improve the quality and compliance of our research and to inform future educational programs and research policies.
To safeguard the integrity and success of all research undertaken at La Trobe University, part of our Risk Based Monitoring framework includes undertaking research audits to review how the research is being carried out, to identify and correct non-compliance to mitigate potential risks that may compromise the safety and wellbeing of research participants, animals and/or the environment.
The scope of audit includes all project documentation for compliance with the applicable legislation, regulations, guidelines and La Trobe University policies, procedures, and Standard Operating Procedures (SOPs), including:
- NHMRC Australian Code for the Responsible Conduct of Research (2018)
- NHMRC Australian code for the care and use of animals for scientific purposes (2013, updated 2021)
- Gene Technology Act (2000)
- Gene Technology Regulations (2001)
- Biosecurity Act (2015)
- NHMRC National Statement on Ethical Conduct in Human Research (2007, updated 2021)
- ICH GCP E6 R2
- La Trobe University Policies and Procedures:
- LTU Research Animal Ethics Procedure
- LTU Research Biosafety and Biosecurity Policy
- LTU Research Biosafety and Biosecurity Procedure
- LTU Research Human Ethics Procedure
- LTU Research Integrity Policy
- LTU Research Data Management Policy
- LTU Research Governance Policy
- LTU Research Clinical Trials Policy
- and all relevant La Trobe University SOPs and Guidelines (see the Policy Library)
Glossary of Terms
- AEC: Animal Ethics Committee
- CTA: Clinical Trials Approval (TGA Scheme)
- CTN: Clinical Trials Notification (TGA Scheme)
- Desktop Audit: Desktop audits review documentation only and do not require face to face meetings or site visits. These are usually conducted by the relevant ethics committee who delegate this responsibility to the EIB team.
- EIB: Ethics, Integrity and Biosafety office
- Onsite Audit: This type of audit involves the EIB team and members of the relevant ethics Committee visiting the space where the study is being conducted, examining all study files, source data, observing procedures like randomisation and consenting processes. The Principal Investigator is required to attend the first and closing meeting. PI’s will be informed if an onsite audit is requested and given 4 weeks’ notice.
- PI: Principal Investigator
- SOPs: Standard Operating Procedures
- TGA: Therapeutic Goods Administration (Australia)