Clinical Research Development Office

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Guidance Materials

If the document you are looking for is inaccessible from this page, please email: crdo.info@mcri.edu.au with your request.

If you have questions or suggestions for further guidelines please contact Julie Smith, Clinical Research Development Officer, Research Development & Ethics on crdo.info@mcri.edu.au or 9345 6362.

 

Campus Clinical Research Guidelines

Guidelines are useful to assist researchers conduct clinical research efficiently and to a high standard. Guidelines are needed to:

  1. Facilitate good quality research and assist clinical researchers by guiding them through clinical research processes
  2. Ensure the campus complies with regulatory requirements.  

CEBU, APPRU and CRDO are developing a set uniform guidelines which can be adopted for clinical research across the RCH/MCRI/UMDP campus. Over the coming months (late 2011 to early 2012) the following guidelines will be made available:

The following additional guidelines are planned:

  • Budgets
  • Preparing for an audit
  • Change of study personnel
  • Training of staff
  • Generally running of a study
  • Structure of a trial team
  • Monitoring
  • Withdrawal
  • Data Monitoring Committees

 

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.

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Getting Started:

The following documents may assist you in getting your clinical research project started

Developing your research idea

Protocol Development

A research protocol is the document that outlines the study plan for a clinical research project. The study protocol must be carefully designed to safeguard the health and safety of the participants, as well to as answer specific research questions.

Before you begin writing a protocol for a research project, a comprehensive guide outlining the steps involved is available to download and read:

 

Choice of protocol template

The protocol template best suited to your study will depend on the study's design, which is determined by your research question.  CRDO has developed protocol templates to assist you in writing a research protocol.  The templates are a guide only, and are annotated with generic advice.  Some subsections and suggestions will not be appropriate for your specific study.

If you are doing an Experimental (intervention) study such as a Randomised Controlled Trial of an Investigational Product (eg sponsored drug trial), then use the template:

You will find information on how to fill in each section in the accompanying document:

Observational studies

If you are doing an Observational Study such as a cohort, case-control and cross-sectional designs where there may be study procedures but no study interventions, the following template is available to fill in:

You will find information on how to fill in each section in the accompanying document:

If you are not sure which template is appropriate for your study, please contact CRDO for advice on the structure or contents of your protocol.

 

Submitting your project to the Human Research Ethics Committee (HREC)

Detailed information on which documents are required as part of a submission to HREC for approval can be found on the RCH HREC website.

Information on writing a Patient Information and Consent Form (PICF) can be found on the RCH HREC website.  Separate templates are available for PICFs for patients and parents/guardians and for clinical studies, drug trials and studies that feature an interview or questionnaire.

The RCH HREC website also provides instructions on completing the PICF, tips for writing in plain English and standard wordings for use in Patient Information and Consents forms.

Information and links to the relevant application forms (the DHS modules or the National Ethics Application Form (NEAF) are available.

Finance and budgeting for research

Setting up a Data and Safety Monitoring Board (DSMB) 

Registering your trial

Many journals require trials submitted for publication be registered on an approved Clinical Trials Registry.  Ideally trials are registered prior to their commencement.  Registration requires researchers to enter information on their hypotheses, therefore they should be clear from the outset about what information is being collected and why, and how it is to be analysed.  The registration process sees researchers more accountable for their study and results may assist in reducing publication bias.  More information can be found on the following website.

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Clinical Research Study Binders

CRDO has developed Clinical Research Study Binders for clinical researchers to identify, maintain and organise the documents essential for the management of a clinical research study.  These binders are FREE lever arch files featuring pre-labelled sections which are preassemble with contents and guidance pages.

If you wish to customise the contents page for your study binder, download the following file and adapt it for your study:

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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Setting up your Study

Data Management Planning


Documentation of project information can be an invaluable resource to later members of the project team and to other researchers that come to investigate your project and its data post project completion. 

See the Data Management Plan website where you can download the Data Managment template.

 

 

Suggestions to help your project run smoothly

 

Guide to Recruiting Clinical Research Coordinators & Assistants

When you are putting together a Research Team you want to get the right person for each job, and this starts with developing a Position Description. CRDO is able to work with you to help you through the process. With the help of some senior members of the hospital and the MCRI HR we have also developed some tips on what to look for when recruiting your Research Staff.  The template for a Position Description below was a collaborative effort by Developmental Medicine, CRDO & MCRI HR. For further assistance contact the MCRI HR Department or crdo.info@mcri.edu.au

 

Reporting Adverse Events (AEs) to HREC (See Investigator's Responsibilities in Research)

HREC Audits

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Other helpful documents

Useful websites


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