Clinical Trial Governance
Clinical Trials at Monash University
Clinical trials conducted at Monash University must be ethically sound, scientifically robust, and compliant with national and international standards. Responsibility for trial conduct is shared across research teams, sponsors, and institutional support services.
Governance and Accountability
Clinical trials at Monash must align with the requirements of:
- NHMRC guidelines, including the National Statement on Ethical Conduct in Human Research
- TGA regulations, including the Clinical Trial Notification (CTN) or Approval (CTA) schemes
- International standards, including ICH Good Clinical Practice (E6 R3)
Researchers are expected to ensure:
- HREC and SSA approvals are in place before recruitment
- The trial is publicly registered (ANZCTR) before enrolling participants
- Safety monitoring and adverse event reporting obligations are met
- Delegation logs and data systems are secure and auditable
What Is the Roadmap?
The Clinical Trial Governance Roadmap guides Monash University researchers through each stage of the clinical trial lifecycle, from feasibility and ethics to closure and results dissemination.
It aligns with:
- National frameworks: NHMRC Clinical Trials Governance Framework, TGA regulations
- International standards: ICH Good Clinical Practice (E6 R3)
The roadmap provides guidance, responsibilities, and key actions for each step, helping ensure trials are conducted ethically, safely, and in accordance with regulatory expectations.
