Clinical Research Governance Process

Clinical Research Governance Process

MQ Health Clinical Research Governance Process

Will you require Clinical Research Governance authorisation?

If you are planning on conducting a clinical research project or clinical trial at MQ Health premises (Macquarie University Hospital, associated clinics and the Faculty of Medicine and Health Sciences), involving patients or staff, you are now required to have a Clinical Research Governance authorisation before its commencement.

Note: Clinical research governance authorisation is a separate process from an ethics review.

You will need to receive your governance endorsement letter before applying for ethics approval by Macquarie University's HREC.

How does it work?

The MQ Health Clinical Research governance is a two-stage process:

  • Stage 1: Initial review and MQ Health governance endorsement (before ethics submission).
  • Stage 2: Final governance authorisation (after all approvals are in place).

The focus of the clinical research governance process at MQ Health is to:

  • assess the feasibility of the proposed clinical research project;
  • consider the resource implications for MQ Health;
  • identify and manage any unusual insurance or other risk(s);
  • ensure relevant sign-offs are in place to meet institutional obligations.

For more information about the process and associated timelines, please visit the CRG website.

Forms, templates, “decision support” tools and Frequently asked questions are also available to support you.

If you have any questions related to the MQ Health CRG process, please contact the Clinical Research Manager, Dr Yordanka Krastev at clinical.research@mqhealth.org.au or (02) 9850 2834.

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