We aim to provide expert guidance for every research journey, as it is important to us that you begin with confidence.
The below options provide guidance for the key factors to consider for different projects.
If the drug/device you are using is not approved for the purpose for which you will be using it for, you must submit a CTN to the TGA + dosier package (TGA equivalent of a CTN).
For AI: if you are using a platform that needs to be integrated into the Monash Health landscape, you will require cybersecurity checks before it can be implemented and approved by the HREC.
Otherwise, for everything else seek HREC and SSA approval. Please see the Ethics and Governance Submissions for further information.
Please ensure you have read and understood the Research Ethics and Governance -Sponsor Responsibilities in Investigator Initiated Studies procedure.
You will need to submit a Human Research Ethics Application (HREA) for ethics approval and a Site Specific Assessment (SSA) application for governance/SSA Authorisation. Please see the Ethics and Governance Submissions for further information.
Please ensure you have read and understood the GMO and Gene Therapy Trials – Human Research Ethics Review & Site Authorisation/Governance.
You will need to submit a Human Research Ethics Application (HREA) for ethics approval and a Site Specific Assessment (SSA) application for governance/SSA Authorisation. Please see the Ethics and Governance Submissions for further information.
You will need approval for the biobank involved in the project. To do so you must secure approval from your institution’s relevant ethics committee. Please visit the Human Research Ethics Review webpage for further information.
Please also note that if the study is being conducted at a Monash Health site, you will also require Site Specific Authorisation. Please visit Site Authorisation webpage for further information.
If you have a quality assurance or a minimal risk research project you may want to check out the Quality Assurance & Minimal Risk Research Improvement projects webpage.
If you are unsure about what which category your project comes under, please contact us.
Please note that Monash Health does not have a low-risk pathway for research projects.
If you have a quality assurance or a minimal risk research project, please see Quality Assurance & Minimal Risk Research Improvement Projects webpage.
Did you know that all clinical staff employed by Monash Health at any campus of Monash Health are eligible to access the Biostatistical Consulting service at no cost for the initial consultation?
The MCHRI Biostatistical Consulting Service provides support for Monash Health and Monash University staff and students in the development, execution and reporting of clinical research studies, including:
Please see Biostatistics Consulting Services page for further information.
Writing consent forms?Â
Please note that Monash Health will accept the following PICF templates as they have been prepared in the Australian context:
Before writing any consent forms for you project, please ensure you have read and understood following procedures:
Got a waiver of consent for your project?Â
Please see the Waiver of Consent to ensure you understand the waiver of consent requirements.
A study protocol is a comprehensive plan or document that outlines the design, objectives, methodology, statistical considerations, and organisation of a research project. It serves as a blueprint for the study, ensuring that all aspects are well-thought-out, standardised, and consistently applied.
Please visit the Planning a Research Project webpage for guidance on how to develop a study protocol.