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Launching Pad

Clinical research resources at the Melbourne Children's

Information and support  

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.

The protocol is essential for study conduct, review, reporting, and interpretation. There are 3 protocol templates available (outlined below) - if you are unsure which template is best for your study please email crdo.info@mcri.edu.au

1. Clinical Trial (drug/device intervention) annotated template (last updated  29 November 2019) 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. 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.  Clinical Trial (intervention is not drug/device) annotated template (last updated  2 September 2019) 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.

3. Observational Studies annotated template (last updated  4 June 2019) for research that is not a clinical trial 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. 

A note about qualitative research: There are currently no templates for qualitative research, however, for advice in developing your protocol/ethics application please contact the MCRI Qualitative Research Special Interest Group at qual.research@mcri.edu.au  

Tools and templates
Training
Information and support
Tools and templates

In the rare instance a drug/device does not have another organisation responsible for creating and maintaining an Investigator's Brochure, please refer to the SOP for:

Trial Sponsorship

Investigator-initiated clinical trials (i.e. an initiated and organised by an individual rather than an external collaborative network, company or organisation) need to request that MCRI acts as the legal representative for a trial, thereby acting as the Sponsor. 

Data Safety Monitoring

Training

For all workshops, go to the CRDO workshops page 

  • Good Clinical Practice 
  • Safety oversight, monitoring & reporting in clinical trials
  • Monitoring investigator-initiated clinical trials
Information and support

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.

Tools and templates
Training
Budgeting for research workshop (internal only)
Information and support

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.

Tools and templates 
Training 
Budgeting for research workshop (Internal only) 
Information and support 
For campus research support (Grants Office, CRDO, MCTC) refer to Campus research support  
Tools and templates

For more information please refer to "Clinical trials design and oversight" & "Risk management and safety reporting"

Information and support

For a CTN application contact MCTC by emailing crdo.info@mcri.edu.au

All research conducted on or by the Melbourne Children's campus must be approved by a Human Research Ethics Committee (HREC) before it can commence. Projects are also reviewed by the Melbourne Children's Campus 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.   

Tools and templates

The RCH Research Ethics Governance web pages provide comprehensive information on all aspects. For a visual summary, refer to the process maps shown below: 

Training
Information and support

For campus research support (REG, CRDO) refer to the Campus research support page

For campus policies on research conduct refer to the Campus policies page 

Refer also to the National/International guidance page for national/international guidance

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.

Tools and templates

The RCH Research Ethics Governance web pages provide comprehensive information and templates.

See also the CRDO Guidance Recruitment, Screening & Enrolment and associated template forms:

Training
Information and support
 

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

Tools and templates
Training

CEBU provides advice and consultation as well as a range of training courses (research methods, data management and use of STATA & REDCap)

The CRDO GCP course also covers some aspects of data collection and management in more limited detail.


 
Information and support

For campus policies on use of and access to health data for research refer to the Campus policies page - many of the categories on this page apply

For national policies refer to the National/International guidance page and check the relevant section

  • privacy and guardianship
  • research conduct (especially the NHMRC Code and supporting documents, and the National Statement)
  • clinical trials 

See also FDA guidance on electronic data. 

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, contact the  MCRI Biobanking Facility (part of the Melbourne Children's Bioresource Centre).  

Tools and templates

CRDO procedure SOP Sample collection and handling

Campus support 
Information and support

For campus policies on biospecimen collection and management refer to the Campus policies page

For national policies on biospecimen (including human tissues, gene technology, embryo usage) refer to the National/International guidance page

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 (ARPANSA) and complete the necessary forms required by the Research Ethics and Governance Office.

Campus support 
Information and support

Tools and templates

Safety Reporting

The RCH Research Ethics Governance web pages provide comprehensive information.

Risk mitigation

Training

For all workshops, go to the CRDO workshops page 

  • Safety oversight, monitoring & reporting in clinical trials
  • Monitoring investigator-initiated clinical trials
  • The CRDO GCP course also provides helpful information on safety monitoring and reporting 
Information and support
Tools and templates

CRDO has developed a suite of documents to support researchers including: 

Training

Trial monitoring (Internal staff only)

Information and support

Good quality data analysis will translate raw data into meaningful results which can be published in peer review journals. In order to change practice through research it is essential to have high quality data. 

Training
  • CEBU provides advice and consultation as well as a range of training courses (research design and methods, use of STATA)
Information and support
Tools and templates

CRDO has developed guidance for what essential documents must be in place and/or retained before, during and after a study.

For single site studies refer to the Investigator Site File (previously known as the /Study Binder) - email Crdo.info@mcri.edu.au to request a paper or electronic folder (or both) for your research project. 

For multi-site studies - where MCRI is leading the study and/or is a Lead Site refer also to the Study Master File.

Useful forms & templates 

Refer also to the CRDO guidance Copying and Certifying Essential Documents

Training
Information and support

The template below provides an abbreviated guide to the tasks involved in setting up, conducting and completing a study.

Tools and templates
Information and support

For campus research support (CRDO & MCTC) refer to Campus research support

All members of the study team must be appropriately trained and qualified to perform the research procedures they undertake. The Principal Investigator must document the tasks he/she delegates to study team members. Keeping records of the team and their activities is essential for evaluating the conduct of the study.

Tools and templates
Information and support

For campus research support (CRDO/MCTC) refer to the Campus research support page