Research Governance

As part of the Research Governance Framework, Monash Health facilitates training for researchers through a Research Governance Seminar series, provides access to the biostatistical consulting service, provides advice to researchers prior to submission of ethics and governance applications and provides ongoing monitoring of research through audits.

A project may be audited for a number of reasons:

• At the request of the Human Research Ethics Committee, following a protocol violation or following a significant change in classification of risk;
• Following a complaint;
• Random Selection;
• Following an insufficient Progress Report being submitted on an annual basis;
• Researchers are encouraged to view the Guidelines for Auditing of Research, the Self Audit Tool and the Short Audit Tools.

Monash Health has developed a suite of Standard Operating Procedures which are updated regularly and are available via PROMPT for all Monash Health users. In the event, that an external researcher requests access to an SoP, please email research@monashhealth.org with a request and the relevant SoP will be emailed as a PDF document to you.

Further Monash Health has adopted the National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia published in February 2021, developed by the Clinical Trials Project Reference Group (CTPRG) and endorsed by all states and territories, the TGA, and the NHMRC.

The National Clinical Trials Governance Framework

The National Clinical Trials Governance Framework (NCTGF) integrates clinical trial service delivery into routine health service provision by embedding clinical trial governance into corporate and clinical governance of health services. The NCTGF focuses on two key standards from the National Safety and Quality in Healthcare Service Standards:

• Standard 1 – Clinical Governance
• Standard 2 – Partnering with Consumers

For more information about the implementation of the NCTGF at Monash Health, please contact the Research Support Services team – research@monashhealth.org.

Useful resources

• The National Clinical Trials Governance Framework and User Guide
• Overview of the National Clinical Trials Governance Framework Factsheet
• Resources for the National Clinical Trials Governance Framework (The Australian Commission on Safety and Quality in Health Care)

To view our procedures, templates and for other useful information, please our Forms Library.

Contact information