Resources - Research

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.  

Protocols

Before you start to write a new protocol, read through this guidance document: Developing, amending and adhering to research protocols. This provides information on why you need a protocol, what information needs to be included and where to seek information and help. 
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 crdo.info@mcri.edu.au

  • Drug/device clinical trial annotated template WORD (last updated 11 June 2015)

    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.

  • Non-drug/non-device intervention template WORD (last updated 15 November 2015)
    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.
     
  • Non-intervention study annotated template WORD (last updated January 2013)
    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.
     
  • FileObservational Studies annotated templateWORD (*NEW* 13 April 2017)
    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. 

Project Management

*NEW* Template Version 12 April 2017

This template document is a guide only and lists an abbreviated set of tasks, which cover trial set up, conduct and completion. 

Useful Tools

Research Measures Library
Useful tools and free measures designed to assist researchers conducting their research.
 
Translation Toolkit

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 crdo.info@mcri.edu.au 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. 

Study Binder (Investigator Site File) Guideline

This guideline details 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 conjuction with this guideline.  For those that 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. 

Research Forms and Templates 

Updated April, 2017

CRDO, along with the Melbourne Children's Trial Centre (MCTC) and Research, Ethics and Governance (REG) are starting to roll out a number of SOPs designed to help research teams ensure Good Research Practice. If you have a request for a particular SOP please don't hesitate to contact us.  

National Research Regulations and Guidelines