Clinical research and investigator initiated clinical trials
Four steps of MQ Health Governance authorisation - new clinical research projects and investigator-initiated clinical trials
We encourage you to utilise the resources and guidelines available on this website to prepare your Clinical Research Governance application form, and to seek advice and assistance from the Clinical Research Manager early if you are not clear about the clinical research governance process.
Step 1: Determination of the nature of the project
- You should assess whether the proposed project is a research or an audit, quality assurance, or surgical innovation activity, by using the decision support tool.
- If you determine that the project is an audit, quality assurance, or innovation, you need to apply for approval by the Clinical Innovation and Audit Committee (CIAC). Please complete a CIAC application form, CIAC project synopsis with supporting documents and submit electronically to firstname.lastname@example.org.
- If you determine the project is research, please complete a Clinical Research Governance application form and clinical research project synopsis or full research protocol and submit to email@example.com.
- For research, a further decision is required to determine whether the project is clinical research or a clinical trial. You might find the decision support flowchart (clinical research vs clinical trial) helpful at this point.
- If you are unclear as to the precise nature of your project, please contact the Clinical Research Manager via email firstname.lastname@example.org or phone: +61 2 9850 2834.
Preparation of documents for clinical research governance review
- Please refer to the detailed guidelines for CRG application form and associated documentation. To organise appointment with the Clinical Research Manager for assistance or advice, please send an email to email@example.com or call +61 2 9850 2834.
- Please 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 study, MMI has recently introduced a fee for this service. Please contact the Chief Research Facilitator for MMI via firstname.lastname@example.org to obtain a quote prior to commencing your application.
Step 2: Initial MQ Health governance endorsement
Clinical Research Manager and Clinical Research Executive undertake feasibility assessment and provide initial governance endorsement after complete submission
The purpose of the feasibility assessment is to:
- determine whether the research team 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.
How does it work?
Upon receipt of all governance documents from you, the Clinical Research Manager will pre-review and determine the level of MQ Health governance endorsement required, which depends on the level of risk of the project. If any clarifications are required, the Clinical Research Manager will contact you for further details.
After a review by the Clinical Research Executive, a governance endorsement letter will be sent to you by the Clinical Research Manager, specifying the conditions of the governance endorsement.
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.
Upon receipt of the governance endorsement letter you must proceed to Step 3 and seek relevant approvals specified in the letter.
Step 3: 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.)
- All applications must be submitted via the new Human Research Ethics Management System. For more information about this system, how to submit new applications and the management of existing applications, please refer to the Human Research Ethics Management support page.
- Applicants from the Faculty of Medicine and Health Sciences, or who are conducting data linkage research; clinical trials (this includes research using randomised trials or interventional studies; medical and health research; or the use of human specimens must complete a Human Research Ethics Application Form (NHMRC). This should be appended to the HREA and other applications form in the Macquarie University Human Research Ethics Management System.
If you have any questions you can contact the MQ Ethics Secretariat at email@example.com
Research agreement/contract review and execution
Some clinical research projects or investigator-initiated clinical trials would have funding agreement or other type of contractual agreements in place, associated with the grants obtained to fund the study. Please check your ten-digit IRIS reference number, e.g 92018XXXXX.
If you need any assistance with research agreements/contracts for your clinical research project or investigator initiated clinical trial, please contact the Clinical Research Manager.
Indemnity and insurance
For insurance purposes, the critical point is what the Macquarie University involvement in the research is, rather than the person who is conducting the research.
Current clinical trial insurance is a “no fault” insurance with a broad coverage of human research. All clinical research involving human participants (not only clinical trials) is covered under the policy. This includes projects using patient health data and observational studies.
The insurances vary depending on the University involvement in the research.
- For Macquarie University sponsored research, the clinical trial will be insured after obtaining ethics approval from Macquarie University HREC.
- For Commercially sponsored studies– the sponsor must hold appropriate clinical trial insurance policy coverage. NSW Health has published a Policy Directive which require commercial sponsored trials to maintain a limit of liability of no less than $20 million for any one occurrence in the aggregate and maximum $25,000 retention.
If you have any insurance related questions for investigator-initiated clinical trial and other clinical research study, you should contact the Clinical Research Manager, who will liaise with the MQ insurance if necessary.
Service provider approvals
- The governance endorsement letter will specify what approvals need to be obtained. This could be from the Macquarie University Hospital (MUH), the pharmacy, Macquarie Medical Imaging (MMI), pathology, or the Faculty of Medicine and Health Sciences PC2 laboratory.
- You should communicate via email and obtain required service providers approvals using this template.
- Once approval is received, please forward it to the Clinical Research Manager at firstname.lastname@example.org.
Clinical Trial Notification (CTN) or Clinical Trail Exemption (CTX) to the Therapeutic Goods Administration (if applicable)
* eCTN submission to the Therapeutic Goods Administration (TGA) is required if:
- A product for the trial is not entered on the Australian Register of Therapeutic Goods (ARTG), including any new formulation of an existing product or any new route of administration; or
- The proposed use of a registered or listed product is outside the conditions of its marketing approval.
eCTN submission if Macquarie University is the sponsor:
- The eCTN submission for Macquarie University is done by the Ethics Secretariat at the Macquarie Research Office.
- Macquarie Research Office has an institutional account with TGA and an authorised person to be the institutional administrator.
- You need to liaise with the Ethics Secretariat and supply the full project details, including all site details before the CTN application can be lodged at the TGA portal.
- Please note that HREC approval is required before CTN submission.
- Credit card payment of the CTN is preferable.
For more details about the process, please contact the Ethics Secretariat at: email@example.com.
Timeline: Depending on the complexity of your project, you should allow at least 20-25 working days for obtaining the required approvals.
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 governance authorisation letter when the following is in place:
- Final MQ HREC approval;
- Confirmation of executed research agreement/contract;
- Evidence of required service providers’ approvals (if applicable);
- Any other condition stipulated in the initial governance endorsement is met.
Timeline: 1-2 working days
Before you start recruitment
If your study meets the WHO/ICMJE 2008 definition of a clinical trial: any research study that prospectively assigns human participants or groups of humans to one or more health related interventions to evaluate the effects on health outcomes, it should be registered in a clinical trial registry.
The Australian New Zealand Clinical Trials Registry (ANZCTR) is an online registry of clinical trials being undertaken in Australia, New Zealand and elsewhere, available at http://www.anzctr.org.au.
Clinical trials should be registered prior to the enrolment of the first participant. The ANZCTR recommends commencing the registration process at least 3 weeks prior to the anticipated recruitment start date.
Prospective trial registration is an ethical obligation and is increasingly required by medical journal editors as a precondition of publication. If you are unsure if registration is required, please contact the ANZCTR at firstname.lastname@example.org.