Fully-sponsored clinical trials

Determine the nature of the trial and complete sponsor's feasibility

The Principal Investigator (PI) and CTU determine the nature of the clinical trial and complete the sponsor's feasibility.

• The clinical trial feasibility assessment is usually conducted by the sponsor with direct input from the PI. The PI and/or the CTU can complete the sponsor’s feasibility assessment without initial input from the Clinical Research Executive.
• For fully-sponsored clinical trials, the first point of contact for the PI is the CTU. The PI should liaise with the CTU about the sponsor’s feasibility assessment. If Macquarie University is chosen by the sponsor to participate in the clinical trial, the sponsor will contact the PI and the CTU.

Initial MQ Health governance endorsement

The CTU completes the abbreviated MQ Health clinical research governance (CRG) application form for fully sponsored clinical trials on behalf of the PI.

The CRG form and relevant protocol should be submitted to clinical.research@mqhealth.org.au for review and assessment by the Clinical Research Executive (see flowchart of the process and the explanation of governance review).

Timeline: 5–10 working days after complete submission.

The clinical research manager will send the CTU and PI an initial governance endorsement letter, stipulating the conditions of the governance endorsement.

Note: The MQ Health governance assessment and endorsement confirm MQ Health's support of the project, but are not the final authorisation to start the project.

Ethics, insurance and contacts 

CTU prepares and submits the following documents:

• ethics submission material to Macquarie University HREC
• contract/agreement for execution
• indemnity and insurance.

Note: It is the sponsor's responsibility to lodge the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) scheme (previously titled Clinical Trial Exemption (CTX)), with the Therapeutic Goods Administration (TGA) after ethics approval.

Final governance authorisation

Once the required activities of Step 3 are completed, the CTU submits the Evidence of Final Approvals – CTU clinical trials form to confirm the:

• final Macquarie University HREC approval
• executed Clinical Trial Research Agreement (CTRA)
• agreements with service providers and/or MUH (if applicable).

The clinical research manager will then issue the final MQ Health authorisation letter.

Timeline: 1–2 working days