Governance authorisation for new clinical research

Use the resources and guidelines below to prepare your clinical research governance (CRG) application.

About the process

See the four steps required in this process. Seek advice and assistance early if you are not clear about the process.

Prepare your application documents for review

Download detailed guidelines for CRG application form and associated documentation.

Complete a clinical research governance application form and either a:

Then submit to clinical.research@mqhealth.org.au

Contact the clinical research manager to organise an appointment for assistance or advice.

Note: If you require services from Macquarie Medical Imaging (MMI), it is likely that it will incur a fee. For example, if you are requesting imaging data for a retrospective research study, MMI has research fees for this service. Obtain a quote prior to commencing your application. Contact the MMI research facilitator at mmi.research@mqhealth.org.au.

Initial MQ Health governance endorsement

The clinical research executive undertakes a feasibility assessment and provides initial governance endorsement after complete submission.

Process

Upon receipt of all governance documents from you, the Clinical Research Support Team will pre-review your application. If any clarifications are required, the team will contact you for further details.

After a review of your application by the clinical research executive, the Clinical Research Support Team will send you a governance endorsement letter, specifying the conditions of the governance endorsement. You must seek the relevant approvals specified in the letter (see Step 3).

Timeline: 5–10 working days after complete submission.

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, contracts and service provider approvals

Following the governance endorsement letter from MQ Health, you prepare and submit documents for ethics review, as well as any other required documents (eg research agreements, service providers’ approvals etc).

Ethics review

All ethics applications must be submitted via FoRA. Learn more about human research ethics, including information about the FoRA system, how to submit new applications and the management of existing applications.

If you have any questions you can contact the ethics secretariat at ethics.secretariat@mq.edu.au.

Research agreement and/or contract review and execution

Any research-related contracts and agreements related to your research project must be submitted to the University’s Research Awards Team to ensure they are acceptable to you and to the University. More information about the process can be found on the University intranet.

Note: Only the Deputy Vice-Chancellor (Research) or their delegate is authorised to sign research contracts or agreements on behalf of Macquarie University.

If you have any questions related to research agreements and/or contracts, contact researchcontracts@mq.edu.au.

Service provider approvals

The governance endorsement letter will specify what approvals need to be obtained. These could be from:

Submitting the approvals: Once the various approvals are received, email the evidence to the Clinical Research Support Team at clinical.research@mqhealth.org.au, noting the initial governance endorsement number.

Timeline: Depending on project complexity, allow at least 20–25 working days for obtaining the required approvals in this step.

Final governance authorisation

The Clinical Research Support Team will issue the final MQ Health governance authorisation letter when the following is in place:

  • final MQ HREC approval
  • confirmation of executed research agreement/contract (if applicable)
  • evidence of required service providers’ approvals (if applicable)
  • any other conditions stipulated in the initial governance endorsement are met.

Your project may commence after you have received the final goverance authorisation.

Timeline: 1–2 working days