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Resources - Research

If you know which document you need, you can use this page to quickly locate it.

For more detailed information,  head to the “Launching Pad” on the RCH website (also hosted by CRDO). The Launching Pad enables you to access all documents on this page but also guides you through each of the major stages of a research project, connects you to the key supporting departments across Melbourne Children's Campus and provides links to campus and national research regulations, guidelines and procedures.   

PROTOCOL TEMPLATES

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 3 protocol templates available. If you are unsure which template is best for your study please email crdo.info@mcri.edu.au

Clinical Trials

1. Clinical Trial (drug/device intervention) annotated template WORD (last updated  4 May 2018) 

Why use this template? This template is appropriate for clinical trials of drug, biologic or device interventions. These may be investigational products* or marketed products being used within the conditions of their TGA approval. 
* 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 trial.
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.

2. FileClinical Trial (non-drug/non-device intervention) template (last updated  24 May 2018) 

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

3. Observational Studies annotated template WORD REVISION NOW IN PROGRESS

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 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. 

Contracts, Indemnities & CTNs - a Process Map

* For a CTN application contact MCTC.

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 and also here as:
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

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

Standard Operating Procedures (SOPs), Guidance Documents & Forms/Templates

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. Investigators must 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.
Guidance documents
CRDO has 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.
* Both guidelines detail what needs to be included - 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. 
 

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.