Prior to commencing your research, the project must undergo a Research Governance review also referred to as a Site-Specific Assessment (SSA). This review is in addition to the Human Research Ethics Committee (HREC) review. Importantly, a research project being conducted at the QEI must hold both Scientific Committee (SC) and HREC approvals as well as Research Governance authorisation before any project-related activities can start.
Research Governance authorisation includes consideration of the following:
Applications for Research Governance authorisation must be made on the QEI SSA form. The SSA application for a research project can be submitted to the Research Governance Office (RGO) at any time. The scientific/ethical review by the HREC and the SSA may occur in parallel. However, any documentation that has been amended during the HREC review and approval process must also be forwarded to the RGO.
For information on the Medicines Australia Clinical Trial Agreements and Indemnification please refer to the Medicines Australia website.
For information regarding CTN/CTX Applications please refer to the Therapeutic Goods Administration website.