Developed to assist Victorian public entities engaged in the conduct of clinical research, the toolkit provides essential information, templates and policies that enable and support good research governance practices.
The core elements that are represented in the Research Governance Toolkit are:
- research ethics
- induction, training and accreditation
- legal and insurance
- research finance management
- data and tissue management
- intellectual property and publication management
- research risk management.
- Protocol for review of the First Time in Human Drug Research Proposals under the CTN Scheme [PDF, 1.29MB]
- Agreement for the conduct of Expert Review of a clinical trial [PDF, 19KB]
- Pharmacology and Toxicology Expert Review Document [XLS, 69KB]
- Immunology Expert Review Document [XLS, 57KB]
- Formulation/Manufacturing Expert Review Document [XLS, 68KB]
- Standard Operating Procedures - Good Clinical Practice in Australian Clinical Research [PDF, 1.1MB]
- Research Governance Toolkit [PDF, 2.02MB]
- National Statement on Ethical Conduct in Human Research [PDF, 148KB]
- Clinical Research Site SOPs [PDF, 720KB]
- VMIA CTN Guidelines [PDF, 138KB]
- ACHS Standards [PDF, 136KB]
- The process to access TGA unapproved therapeutic goods [PDF, 125KB]
- Privacy [PDF, 132KB]
- Radiation [PDF, 150KB]
Please contact our Client Services Team on 03 9270 6900 or by email firstname.lastname@example.org.