Guidance materials
Guide to Research Support for Clinical Researchers on Campus
High quality clinical research is not a simple task and often requires specific skills. There are several facilitators on campus that can provide assistance in clinical research. This guide is designed to help you identify, find and utilise these resources available on campus. A joint production of The Royal Children’s Hospital, Murdoch Children’s Research Institute and The University of Melbourne, the guide is designed to help all researchers and clinicians involved in research, in all professions and across all levels of research experience
Protocol Development
A research protocol is the document that outlines the study plan for a clinical research project. The study plan must be carefully designed to safeguard the health and safety of the participants, as well to as answer specific research questions.
Guidance: Developing a protocol for a clinical research project (PDF 380KB)
CRDO has developed a template for researchers developing a protocol for a randomised controlled trial of an investigational product.
We recommend the structure described in this template, based on our experience with clinical research studies. However, this is only a guideline and is annotated with generic advice. Some subsections and suggestions will not be appropriate for your specific study.
Annotated Protocol Template for an RCT of an Investigational Product (PDF 460KB)
Complete the following template to write your study protocol:
Empty Template for an RCT of an Investigational Product (Word 85KB)
The above template is not appropriate for any study that is not a randomised controlled trial of an investigational product.
If you need to write a protocol for a different study design, such as an observational study, or if you are not sure if this template is appropriate for your study, please contact CRDO for advice on the structure and contents of your protocol.
Clinical Research Study Binders
CRDO has developed this guidance document for clinical researchers to identify, maintain and organise the documents essential for the management of a clinical research project.
Guidance: Using a Study Binder in a Clinical Research Project (PDF 670KB)
FREE lever arch files with pre-labelled sections are available from CRDO, preassembled with contents and guidance pages.
Please complete the following form, after reading the guidance document, to request a study binder for your study: Binder Order Form (PDF 76KB)
If you wish to customise the contents page for your study binder, download the following file and adapt it for your study:
Binder Contents Page: Sections 1-24 (Word 60KB)
If you wish to adapt the sample forms included in the guidance document, download the following files and customise them for your study:
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Sample Study Initiation Checklist (Word 60KB)
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Sample Staff Delegation Log (Word 55KB)
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Sample Screening Log A (Word 70KB)
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Sample Screening Log B (Word 90KB)
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Sample Enrolment Log (Word 84KB)
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Sample Subject Identification List (Word 60KB)