In this section
The Melbourne Children's continually strives to find better ways to care for our children. You can be a part of this by developing your own research project as a Principal Investigator or by working as part of a research team.
Great opportunities exist for research on campus, and there is considerable support and resources to facilitate your research project at every step of the way....
Researchers should address consideration of financial interest in both the NEAF (for each investigator section & the duality of interest section) and the application cover letter.
The right study design will ensure you are best able to answer your research question. Assistance from a statistician is important for ensuring a robust research question, study design and analysis plan. The protocol is essential for study conduct, analysis and reporting.
Government funding bodies and philanthropic trusts and foundations award grants and fellowships/scholarships following a rigorous selection process based on scientific quality and significance, and applicant track record. With an overall reduction in the funding pool, an increasing number of applications and increasing budget costs for proposed projects, a strategic approach to writing funding applications is needed.
Protocol templates for clinical trials
The Australian Clinical Trials Handbook (TGA) (PDF)
TGA Note for guidance on Good Clinical Practice
TGA Note for Guidance on Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting (PDF)
TGA Access to unapproved therapeutic goods; Clinical trials in Australia
NHMRC Safety monitoring and reporting in clinical trials involving
therapeutic goods (NOV 2016)
Therapeutic Goods Act
Therapeutic Goods (Medical Devices) Regulations
VMIA Clinical Trials Risk and Insurance Guide
It is essential that studies are designed and conducted to national, state and institutional guidance to assure ongoing protection of research participants' rights, scientific integrity of the research and the generation of credible data. The processes involved in assuring appropriate study design and conduct are referred to as oversight.
As of January 2018 we are awaiting the release of a
number of new guidance documents and templates from NHMRC.
Data and Safety Monitoring Board - Standard Operating Procedure
Data and Safety Monitoring Board (DSMB) charter TEMPLATE
DAMOCLES template charter for DSMB
The template below provides an abbreviated guide to
the tasks involved in setting up, conducting and completing a study.
Study Task Timeline TEMPLATE
Research projects must be appropriately costed to ensure the department and the instituted are protected. Regulatory documents refers to those necessary for reporting the conduct of drug and device trials to the government.
All research conducted on or by the Melbourne Children's campus must be approved by a Human Research Ethics Committee (HREC) and before it can commence. Projects are also reviewed by the Research Governance Manager to ensure compliance with National and local regulations and policies. Ongoing ethics approval and governance
authorisation for projects is subject to satisfactory progress reporting and other requirements – refer to the RCH Research Ethics Governance
website for details.
For all forms for REG applications visit the
Respect for human beings involves giving due scope to people's capacity to make their own decisions. In the research context, this normally requires that participation be the result of a choice made by participants - commonly known as 'the requirement for consent'. An appropriate recruitment strategy is essential to ensure target recruitment numbers are met in order to provide sufficient data to answer the research question. A recruitment strategy will also ensure participants are recruited in line with the necessary guidelines.
Good data management is a foundation of good research. If data are properly organised, preserved and well documented, and their accuracy, validity and integrity is controlled at all times, the result is high quality data, efficient research, outputs based on solid evidence and the saving of time and resources
CEBU provides advice and consultation as well as a range of
training courses (research methods & use of REDCap)
Clinical trials only
All samples from hair and saliva to blood and bone marrow must be collected, stored and destroyed as per National and local guidelines. For long term storage of biospecimens the Biobanking Advisory Committee (BAG) can assist.
Any research that uses ionising radiation (for example an X-ray or CT scan) must comply with the Australia Radiation Protection and Nuclear Safety Agency and complete the necessary forms required by the Research Ethics and Governance Office.
For all forms for REG applications visit the
An adverse event (AE) is defined as any untoward medical occurrence in a study participant, regardless of whether or not it is thought to be related to study procedures or to a study intervention (e.g. an experimental drug or device; a behavioural intervention; a procedural intervention). All adverse events that occur in a study have to be logged, and some reported to an ethics committee or institutional committee.
website provides links to the guidance document and process map (a flowchart)
for safety reporting.
that for clinical trials using a DSMB to oversee the trial you will find links
to the CRDO guidance documents and templates.
The REG website provides links to the guidance document and process map (a flowchart) for safety reporting.
Note also that for clinical trials using a DSMB to oversee the trial you will find links to the CRDO guidance documents and templates.
Documents will be posted shortly.
SOP Monitoring Visit Activities
Essential documents individually and collectively allow for the evaluation of the conduct and quality of a study, and need to be stored appropriately.
CRDO Study Binder / Investigator Site File guidance/template provides full
details of what must be maintained – you will find many useful associated forms
& templates here as well (e.g. Staff signature & delegation log, study
start-up checklist, Screening and enrolment logs, “Note to File” template etc).
For multi-site research, there is also guidance as
to what must be retained by the coordinating site for its participating sites.
The CRDO GCP
course covers elements of document management
Good Clinical Practice (GCP) in Research
Those conducting a study must be appropriately trained and qualified to perform the research procedures they're delegated. Keeping records of the team and their activities is essential for evaluating the conduct of the study.
Good quality data analysis will translate raw data into meaningful results which can be publish in peer review journals. In order to change practice through research it is essential to have high quality data.