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.
There are three protocol templates available. Keep checking back here for the release of two new templates: 'observational' and 'audit'. If you are unsure which template is best for your study please email email@example.com
- Drug/device clinical trial annotated template WORD (last updated 11 June 2015)
- Non-drug/non-device intervention template WORD (last updated 15 November 2015)
- Non-intervention study annotated template WORD (last updated January 2013)
All campus staff planning to undertake a research project have a responsibility to ensure that good financial management practices are in place. This 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 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 for when you are submitting as a lead site, and have to interact with one or more accepting sites. The flowcharts are housed on the Research Ethics and Governance website here.
There is a NEW Standard Operating Procedure and Process flow for the management of adverse events which makes this sometimes complex process much easier to navigate. There are both hosted on the Adverse Event page of the Research Ethics & Governance website.
To help make your research count through better translation, use this toolkit to identify stakeholders and select appropriate engagement methods.
- Translation Toolkit WORD (last updated 4 March 2013)
Use the following examples as a guide when completing your toolkit (examples are intranet only)
- Clinical Translation (Example) PDF
- Public Health Translation (Example) PDF
- Laboratory Translation (Example) PDF
Study Binder 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 CRDO to request a paper or electronic study binder for your trial.
Study binder for studies where MCRI is Lead Site and/or leading a multi-site study – Instructions and template.
Research Forms and Templates
- Study team training log
- Note to File template
- Study start-up checklist
- Study closure checklist
- Template enrolment log
- Template screening log
- Template delegation log
- Template investigator CV
Research SOPs and guidelines
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
- Copying and Certifying Essential Documents
- Data collection for research: source documents and the Case Report Form (CRF)