Governance for University-sponsored trials

Overview of the process for investigator-initiated clinical trials (IICTs) sponsored by Macquarie University.

A clinical trial at Macquarie University is considered investigator-initiated when:

  • the protocol is authored by Macquarie University investigators within the course and scope of their University appointment, and
  • the clinical trial addresses relevant clinical questions and not industry needs.

Sponsorship of a clinical trial by the University is therefore considered and provided on a case-by-case basis. See the decision guidance to determine whether a project is clinical research or a clinical trial.

Review process and sponsorship assessment

The purpose of the MQ Health clinical research governance (CRG) assessment and scientific review of investigator-initiated trials is to address the governance considerations, along with assessing the project for Macquarie University sponsorship.

There are four steps in the investigator-initiated clinical trial review process:

Development and submission of required documents

Prepare clinical trial protocol and supplementary documents

The Principal Investigator (PI) and the research team develop a clinical trial protocol and supplementary documents (see below) for clinical research governance submission.

  • Macquarie University recommends using SPIRIT because it provides evidence-based recommendations for the minimum content of a clinical trial protocol.
  • SPIRIT is widely endorsed as an international standard for trial protocols. PIs should seek biostatistical advice or peer-review from an expert in the field to ensure quality and validity of the research protocol.
Complete and submit application form and associated documents

The PI completes the Clinical Research Governance IICT application form, obtaining all relevant signatures, then submits:

  • the Clinical Research Governance IICT application form
  • the clinical trial protocol
  • signed IICT PI agreement
  • copies of CVs for the PI and research team, demonstrating affiliation with the Macquarie or MQ Health trial site  and training and experience to conduct the clinical trial within the research area
  • copies of current Good Clinical Practice (GCP) certificates for the PI and research team (more information below)
  • itemised study budget/funding information
  • any other supporting documentation relevant to the project, such as scientific review and investigator brochure (if applicable).

Submit your application in one complete project submission package to clinical.research@mqhealth.org.au. Incomplete submissions will be returned to the PI and will require a complete resubmission of all documents.

MQ Health governance, scientific review and conditional endorsement (concurrent review)

  • Applications are reviewed by the Clinical Research Executive (CRE). Refer to the IICT – Flowchart CRG process.
  • For scientific review of the IICT where Macquarie is a sponsor, internal review must be conducted by MQ Health Clinical Trials Scientific Review Panel in parallel with the CRG review. This includes review and advice on merit, scientific validity, and safety of the IICT.
  • For scientific review of the IICT where Macquarie is a site, external review is accepted. External review documentation must be submitted for CRE review.

Investigator-initiated clinical trials will be reviewed free of charge.

Timeline: IICTs are allocated for review at monthly CRE meetings. Outcomes will be sent to the PI within two to three working days of the meeting.

An initial governance endorsement letter will be emailed to the PI by the Clinical Research team, stipulating the conditions of the governance endorsement. These conditions must be satisfied and approved by the CRE prior to project commencement.

Note: The MQ Health governance assessment and initial endorsement confirm MQ Health's support of the project but are not the final authorisation to start the project.

Ethics, insurance and research contracts

Human research ethics submission

Human research ethics applications are managed online.

  1. Log into FoRA using your OneID and password.
  2. Complete the ethics application form titled 'HREA', upload the full protocol and all supporting documents.
  3. Upload the 'CRG endorsement - subject to conditions' letter under the upload section.

For HREC submission deadline and meeting dates, please visit HREC important dates.

For further information visit Macquarie University human research ethics or contact ethics.secretariat@mq.edu.au for support and guidance.

Insurance

Any investigator-initiated clinical trial where Macquarie University is a sponsor or a site, the project has been approved by the MQ HREC, and final governance approval has been granted is covered by Macquarie University Clinical Trials insurance policy.

The MQ Clinical Trials insurance policy does not cover external sites. Specific categories of clinical trials will need to be referred to the insurer via the Office of Risk and Assurance. Please contact the clinical research manager for more information.

Research contract/funding agreement

Macquarie University accepts standard Medicines Australia Clinical trial research agreements (CTRA). Any other templates for research-related contracts and agreements with external organisations must be submitted to the University’s Research Awards Team to ensure they are acceptable to both the PI and the University. See the University intranet for more information about the process.

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

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

Service provider approvals/agreements

The PI is to seek relevant service provider agreements, for example:

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.

Final governance authorisation and confirmation of Macquarie sponsorship

The Clinical Research Executive or MQ Health Executive provides final governance authorisation, and recommendation for Macquarie University sponsorship to the Deputy Vice-Chancellor Research (DVCR) for approval before the project may commence.

The PI must provide evidence confirming that the following conditions outlined in their endorsement letter are in place:

  • final Macquarie University HREC approval letter
  • executed Clinical Trial Research Agreement (CTRA) (or other research contract or agreement, as relevant)
  • agreements with service providers and/or MQ Health Pty Ltd, including Macquarie University Hospital (if applicable).

Note: If the project is run by the MQ Clinical Trials Unit, a submission of the Evidence of Final Approvals – CTU clinical trials form should be sufficient.

The Clinical Research team will initiate the request for DVCR approval for Macquarie University sponsorship. Once approved by the DVCR, the Clinical Research Support Team will issue the final MQ Health authorisation for Macquarie University sponsorship letter.

Timeline: Five working days.

Additional information and resources

Several other resources are available to researchers.

  • Macquarie REDCap manages sensitive health data. REDCap includes data and project management features, as well as ethics safeguards unavailable in other platforms. MQ REDCap is maintained internally at Macquarie University and all data resides in NSW.
  • Macquarie's Yammer REDCap group offers internal user community support. Yammer is a private, university-wide communications and social network platform which allows you to communicate and collaborate with online colleagues online at your desk or on the go.
Data Safety Monitoring Board

A Data Safety Monitoring Board (DSMB) is an independent and multidisciplinary group established to provide oversight of investigator initiated clinical trials (IICTs). This includes clinical trials of non-pharmacological, behavioural and lifestyle interventions, as well as pharmaceutical and device trials.

  • The DSMB will review, at intervals, accumulating clinical trial data, in order to monitor the progress of the trial and to make recommendations on whether to continue, modify or stop the trial for safety or ethical reasons.
  • The duration of the function of individual DSMBs should be stated in the protocol and could vary from study to study depending on the requirements and key time points in the study.
  • IICT – Data Safety Monitoring Board (DSMB) – Terms of Reference (TOR).

GCP training (accredited ICH GCP training) is now offered through the MQ Clinical Trials Unit. Macquarie University has adopted the minimum standards defined by TransCelerate Biopharma Inc to recognise GCP training courses that contain material meeting the minimum criteria agreed to by its member organisations.

Macquarie University Clinical Trials Unit (CTU) offers one-day TransCelerate accredited GCP training free of charge, twice a year. The training is delivered as an introduction to GCP (5-6 hours) or a refresher training session (1.5-2 hours) for staff who just need to update their qualifications.

GCP training sessions

This TransCelerate accredited GCP training session is tailored for all staff involved in clinical research. The training is dynamic and interactive and gives participants an in-depth understanding of GCP and how it relates to everyday research activity. Led by specially trained CTU staff members in partnership with Sophie Mepham GCP™ and Praxis Australia. The training will be delivered over 5-6 hours. GCP Certificate will be provided to all participants on successful completion of the training (TransCelerate accredited).

To register your interest, or for further information on GCP training please contact: clinicaltrials@mq.edu.au.

Note: Macquarie University does not mandate you gain GCP certification through the CTU. Alternative GCP training is offered through many companies who have self-attested and courses meet the TransCelerate GCP Training Minimum Criteria.

Macquarie University endorses using the Good Clinical Practice (ICH GCP) Training Course – Genesis Research Services. This online course is $10 and is designed to define the Minimum Criteria for Good Clinical Practice (GCP) training of investigators and site personnel (based upon ICH E6 R2).

For further information on other externally recognised training providers, visit the TransCelerate Biopharma – GCP Providers webpage.

Clinical trial registries allow you to find clinical trials in Australia. There are two main registries:

For information on other clinical trial registries, visit Australia Clinical Trials Registries.

Clinical Trial Notification (CTN) scheme is a notification process. The clinical trial sponsor must notify TGA of the intent to sponsor a clinical trial involving an 'unapproved' therapeutic good. This must take place before starting to use the goods. The notification form (eCTN) must be submitted online and accompanied by the relevant fee.

eCTN submission to the 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 Clinical Research Support Team.
  • Macquarie University has an institutional account with TGA and an authorised person to be the institutional administrator.
  • You need to liaise with the Clinical Research Support Team and supply the full project details, including all site details before the eCTN application can be lodged at the TGA portal.
  • Please note that HREC approval is required before CTN submission.
  • Credit card payment of the CTN fee is preferable.
  • For further information, contact the Clinical Research Support Team.

Researchers in Australia are required to have adequate experience and qualifications to engage in clinical trials. See training resources available below.

GCP and research principles

Researchers must ensure their projects comply with relevant policies, legislation and guidelines.

See clinical trial guidelines