Governance for fully sponsored clinical trials

Step 1. Principal Investigator (PI) and Clinical Trials Unit (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 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.

Important! Steps 2 and 3 can be undertaken concurrently.

Step 2: 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).

Note: From 2 January 2019, all commercially sponsored clinical trials (full sponsorship) submitted for MQ Health clinical research governance review, will incur a fee of $2000 + GST. Investigator initiated clinical trials and other clinical research projects will be reviewed free of charge.

The purpose of the governance assessment is to:

• Determine whether the institution has the capacity and capability (including hospital and other resources, expertise and participant pool) to carry out a specific clinical research within a given budget;
• Assess whether the proposed research project is in line with the MQ Health strategic priorities; and,
• Ensure that the MQ Health Executive team is aware of and supports the proposed clinical research and whether there are any special insurance issues.

Timeline:  5-10 working days after complete submission.

An initial governance endorsement letter will be sent to CTU and the PI by the Clinical Research Manager, 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.

Step 3: Ethics, insurance and contracts

CTU prepares and submits the following documents:

• Ethics submission material to Macquarie University HREC;
• Contract/agreement for execution; and,
• 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.

Step 4: Final governance authorisation

The Clinical Research Executive or MQ Health Executive provides final governance authorisation, so that the project may commence. The Clinical Research Manager will issue the final MQ Health authorisation letter after CTU confirms that the following is in place via submission of the Evidence of Final Approvals - CTU clinical trials form:

• Final Macquarie University HREC approval;
• Executed Clinical Trial Research Agreement (CTRA); and,
• Agreements with service providers and/or MUH (if applicable).

Timeline:  1-2 working days

Post Final Authorisation (amendment if required)

An amendment request for CRE review after the final governance authorisation generally is not required.

A notification will be required if there is a significant change in the resources or expenses required to conduct the clinical research and clinical trials.

For example:

• Extra hospital beds or clinical space are required.
• Considerable increase in the number of participants to be recruited at MQ Health.
• Expenses not covered by the sponsor that need to be absorbed by MQ Health.

For further information or clarification please contact the MQ Health Clinical Research Manager.