MQ Health Clinical Research Governance Process and Associated Timelines
Coronavirus (COVID-19) update: Face-to-face clinical research
Assessment for recommencement of face to face clinical research at Macquarie University
With restrictions easing on return to campus and in line with the University COVIDSafe plan, the COVID Taskforce has delegated to the MQ Health Clinical Research Executive to approve the recommencement of clinical research, clinical trials and human participant research. This includes accessing and approving the requests for recommencement of face-to-face data collection or contact with human participants both on campus and off campus.
To have your clinical research or clinical trial assessed by the MQ Health Clinical Research Executive, please download and complete the COVIDSafe recommencement form by visiting the Forms, templates, “decision support” tools webpage and submit to email@example.com.
Faculty of Medicine Health and Human Sciences has developed a COVIDSafe guideline for research, teaching and learning, which we recommend you download and read before submitting the application form.
If you have any questions, please contact the Clinical Research team at: firstname.lastname@example.org.
MQ Health clinical research governance
As of March 2018, all research to be conducted at MQ Health premises and involving MQ Health patients or staff will be required to have clinical research governance authorisation before commencement. Desktop research concerning MQ Health but not requiring access to MQ patients, staff or facilities is exempt. Quality assurance, audit and innovation activities are reviewed and approved by the Clinical Innovation and Audit Committee.
The clinical research governance process at MQ Health applies to research that:
(1) is to be conducted at MQ Health site (Macquarie University Hospital (MUH), MQ Health clinics or FMHS PC2 laboratories); and
(2) involves direct interaction with human participants at MQ Health (MUH and/or clinics) and/or use of patient samples and/or data (from MUH and/or clinics).
Note that research being carried out at health facilities that are not part of MQ Health are subject to that facility’s authorisation arrangements and are not further discussed here.
Clinical research governance authorisation is a separate process from an ethics review. The ethics review is conducted by the Macquarie University Human Research Ethics Committee (HREC) or a relevant University ethics sub-committee.
Both ethics approval and clinical research governance authorisation are required before a clinical research project can commence at MQ Health.
Focus of the clinical research governance process
The clinical research governance process at MQ Health will:
- 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.
Forms, templates and tools
Find the clinical research governance application forms, templates and tools
FAQs and definitions
Find out more
Why is a clinical research governance framework necessary?
- To capture all clinical research (including clinical trials) conducted at MQ Health;
- To help identify any issues with the project early;
- To ensure that necessary governance considerations are applied to proposed research;
- To provide a structure and make it easier for investigators to conduct research.
In addition, to ensure:
- The research team has the capacity, capability and financial resources (e.g. funding, approval to use hospital and other resources, relevant expertise and sufficient participant pool) to carry out the proposed clinical research;
- The proposed clinical research is in line with the MQ Health strategic priorities;
- The MQ Health Executive team is aware of and supports the proposed clinical research;
- Relevant approvals are in place before research begins;
- Researchers are well supported to conduct high-quality research at MQ Health.
To assist with this, the MQ Health Clinical Research Manager is a central point of contact for governance queries and to offer general advice and guidance on undertaking clinical research.
The MQ Health governance review and approval process is outlined below, and comprises of two main stages: governance endorsement after feasibility assessment and final governance authorisation after required approvals are in place.
The MQ Health Clinical Research Executive (CRE) assesses the feasibility and quality of proposed clinical research projects and their alignment with the MQ Health strategic priorities. The expertise of the CRE includes the following areas: academic, clinical, clinical trials, research practice and management.
Timelines: Depending on the quality of the project, requested clarifications, and the time taken by the Principal Investigator to respond to the feedback, the governance endorsement and final authorisation (excluding the time for obtaining other approvals such as ethics approval, contract execution, etc.) should take between 6-12 working days. It might take longer if the project is complex, hasn't been adequately planned and/or has significant legal, insurance or resource implications.
Steps of MQ Health Governance authorisation
Note: An overview of the potential clinical research pathways will assist to determine the type of research and best contact for advice.
Clinical research projects and investigator-initiated clinical trials
Step 1: You determine the nature of the project and prepare documents for clinical research governance review.
Step 2: The Clinical Research Manager and Clinical Research Executive undertake feasibility assessment and provide governance endorsement. Timeline: 5-10 working days after complete submission
Step 3: Following written guidance from the Clinical Research Executive, you prepare and submit documents for ethics review, as well as any other required documents (e.g. agreements, service providers’ approvals, etc.). Timeline: Depending on the complexity of your project, you should allow at least 20-25 working days for obtaining the required approvals.
Step 4: Clinical Research Executive on behalf of MQ Health provides final governance authorisation, so that the project may commence. Timeline: 1-2 working days
For more detailed information regarding the 4 steps, visit the page new clinical research proposals or investigator-initiated clinical trials
Fully-sponsored clinical trials
The MQ Health Clinical Trials Unit provides support for sponsored clinical trials. Find out more on the mechanics of the governance process for sponsored clinical trials.
Who to contact?
- General advice on undertaking clinical research and specific advice on clinical research governance process – Clinical Research Manager - email@example.com
- Queries related to fully-sponsored clinical trials – Clinical Trials Unit - firstname.lastname@example.org
- Research funding advice – FMHS Research Support Team - email@example.com
- Ethics advice, HREC review and approval – MQ Ethics Secretariat - firstname.lastname@example.org