For an overview of the research process see the “Launching Pad
”. This will guide you through each of the major stages of a research project, and connect you to the key supporting departments across Melbourne Children's Campus. For additional resources, continue on this page.
Why do you need a protocol?
The protocol is essential for study conduct, review, reporting, and interpretation.
There are four protocol templates available. If you are unsure which template is best for your study please email firstname.lastname@example.org
All protocol templates are currently being revised - in the interim please replace the safety wording in the current templates with the updated wording located in the following document (this reflects the updated NHMRC guidance on safety monitoring and reporting).
Why use this template?
This template is appropriate for clinical trials of investigational products.
An investigational product is defined as: a product not entered on the Australian Register of Therapeutic Goods, including any new formulation of an existing product or any new route of administration; or use of a registered or listed product outside the conditions of its marketing approval.
The investigational product being tested in the trial may be a drug, placebo, vaccine or device, or substance such as an adapted blood product that is being administered to participants. The term ‘drug’ is used commonly in this template to refer to the investigational product, and should be replaced with an alternative term, such as ‘device’ or ‘vaccine’, if this is more applicable to your study.
Trials are usually defined as any experiment in a well-defined population that systematically evaluates feasibility, efficacy, effectiveness, safety, tolerability and clinical usefulness of an intervention.
Why use this template?
This template is appropriate for clinical trials of non-investigational products (drugs or devices). For example this may be a behavioural intervention or an educational intervention. Trials are usually defined as any experiment in a well-defined population that systematically evaluates feasibility, efficacy, effectiveness, safety, tolerability and clinical usefulness of an intervention.
Research that is not a Clinical Trial
Why use this template?
This non-interventional template can be used for studies where the assignment of patients to a particular therapeutic strategy is not decided in advance by a trial protocol. No additional diagnostic or monitoring procedures is applied to the patients. A non-interventional study does not interfere with the choice of treatment, sample collection, or procedures, and the treatment itself should follow standard hospital practices. CRDO recommends this template be used for studies that collect biospecimens, images and other data. Non-interventional studies include Post-Marketing Surveillance Studies, Post Authorisation Safety Studies, Pharmacovigilence Studies, Pharmacoepidemiologic Studies, Drug Utilisation Studies, Retrospective and Prospective Registry Studies. Sample and suggested text are offered in this template. It contains headers and formatting for use in writing your protocol. Refer to the Template for instructions and suggested text. As appropriate, modify the suggested text for your specific protocol.
Why use this template?
This template is appropriate for observational studies. In an observational study researchers observe subjects and measure variables of interest without assigning an intervention to the subjects. In such a study, the intervention that each subject receives is not determined by the investigator but is determined by the natural treatment process.
Budgeting guidance and budget template
All campus staff planning to undertake a research project have a responsibility to ensure that good financial management practices are in place. This guideline on setting up a research budget
and the budget template
will help you cost your project, with useful tips and tricks to ensure you include everything you need. The template is best suited to clinical trials, but can be adapted for other research.
Ethics and governance management
CRDO has created two process flowcharts that will help you manage the ethics and governance processes for single, or multi-centre studies. They detail each of the steps, and the order of the steps you need to follow. This is especially useful in multi-site studies when you are submitting as a lead site, and need to interact with one or more accepting sites. The flowcharts are housed on the Research Ethics and Governance website
There is also a Standard Operating Procedure and Process flow for the management of
adverse events. This makes this often complex process much easier to navigate. There are both hosted on the Adverse Event page
of the Research Ethics & Governance website.
This template document is a guide only and lists an abbreviated set of tasks, which cover trial set up, conduct and completion.
Research Measures Library
Useful tools and free measures designed to assist researchers conducting their research.
To help make your research count through better translation, use this toolkit to identify stakeholders and select appropriate engagement methods.
For Melbourne Chidlren's staff and students only - contact CRDO at email@example.com
to request any of the following examples (completed) which you can use as a guide when completing your toolkit: clinical translation; public health translation; and laboratory translation.
Standard Operating Procedures (SOPs)
CRDO, along with the Melbourne Children's Trial Centre (MCTC) and RCH Research, Ethics and Governance (REG) have a suite of SOPs designed to help to facilitate good research practice and compliance with applicabile regulatory requirements for clinical research on campus. The list below contains all current SOPs - new SOPs are currently being developed, including monitoring and safety reporting. If you have a request for a particular SOP please contact us.
Note: It is the responsibility of the Investigator to ensure that members of the study team have the appropriate skills and qualifications to perform their role in the study. This includes training in SOPs that are relevant to the conduct of the study. Training in SOPs should be documented on the study Training Log.
CRDO have developed a suite of guidance documents to facilitate good research practice. There is some flexibility in the process for the procedures covered, hence the softer approach to make these guidance documents rather than SOPs. The guidance documents available are listed below.
Note: Both study binder guidelines detail what needs to be included in your study binder/investigator site file and why. Below, there are templates such as delegation and recruitment logs to use in conjunction with this guideline. For those who prefer to file electronically (or have a mix of paper and electronic) let us know. We have an electronic file structure we can email you that is identical to the paper version.
Template Forms and Checklists
The list below includes template forms and checklists. The template forms include the various study logs that are required in accordance with ICH GCP Section 8.3 as evidence that infomation related to study staff (training, delegation of tasks), recruitment of participants and documenting important information related to the study (Note to file). Checklists are also available to assist research teams during study feasibility, start-up and study closure.
National Research Regulations and Guidelines