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.
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 firstname.lastname@example.org
- 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.
- Observational 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.
*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.
Research Measures Library
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.
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.
- Study binder (last updated 8 August 2014) Email firstname.lastname@example.org to request a paper or electronic study binder (or both) for your research project.
- Study binder for studies where MCRI is Lead Site and/or leading a multi-site study – Instructions and template.
Research Forms and Templates
Updated April, 2017
- 1. CHECKLIST Study Start-up
- 2. TEMPLATE Signature Log & Delegation of Duties
- 3. TEMPLATE Training Log
- 4. TEMPLATE Screening Log
- 5. TEMPLATE Enrolment Log
- 6. TEMPLATE Note to File
- 7. CHECKLIST Study Closure
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.
- SOP creation. implementation and revision
- Data and Safety Monitoring Board - Standard Operating Procedure
- Data and Safety Monitoring Board (DSMB) charter TEMPLATE
- Copying and Certifying Essential Documents
- Data collection for research: source documents and the Case Report Form (CRF)
- Source Document Plan Guidance and Template