Research process resources: Launching pad

A comprehensive collection of resources to guide you through each of the major stages of a research project.

All researchers are required to conduct research in a manner that meets the standards of the Melbourne Children’s campus and National guidance, protects the safety of all research participants and facilitates the generation of high-quality data. The Launching Pad provides guidance, procedures, and templates to help you conduct your research involving participants efficiently while meeting these standards.

This collection of resources has been developed and compiled by the Clinical Research Development Office (CRDO) and Murdoch Clinical Trials Centre (MCTC).

The resources are based on RCH / MCRI Campus policies, and external National / International guidance.  They support researchers to conduct high quality research including clinical trials and observational research.  Resources to support qualitative research may be found at the Qualitative Research page. For general guidance for conducting research across the RCH / MCRI campus, try the Melbourne Children’s Research Hub.

We hope that you find the resources useful and we ask that you please acknowledge MCRI when using these resources in your research.

Grant writing and management

With an overall reduction in the funding pool and an increasing number of applications and increasing budget costs for proposed projects, you must be strategic when writing funding applications.

Government funding bodies and philanthropic trusts and foundations award grants and fellowships/scholarships following a rigorous selection process based on scientific quality, significance, and applicant track record.

Panels determining these awards may not be familiar with your area, or even have a scientific background. Make sure you can engage with a lay person when explaining your idea.

CRDO Resources

Melbourne Children’s Resources

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Research question, study design, writing the protocol and analysis planning

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. If you are unsure which of the templates below is best for your study, please email 

CRDO Resources

Guidance | Developing, amending and complying with research protocols
  1.  Clinical Trial (drug/device intervention) annotated template (last updated  29 November 2019)
  2. 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.

  3. Clinical Trial (intervention is not drug/device) annotated template (last updated  2 September 2019)
  4. 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.

  5. Observational Studies annotated template (last updated  4 June 2019) 
  6. 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.

  7. Clinical Audits / Quality Assurance protocol template 
  8. This template is appropriate for studies in which the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation. This generally encompasses the systematic collection and analysis of information to make judgements; usually about the effectiveness, efficiency and/or appropriateness of an activity.

  9. Qualitative Research 
  10. 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 

This SOP is only applicable in the rare instance a drug/device does not have another organisation responsible for creating and maintaining an Investigator's Brochure.

Melbourne Children’s Resources

For  CEBU resources including

  • Checklist | Clinical Trial Protocol review 
  • SOP | Statistical Analysis Plan (SAP) - Final analysis
  • SOP | Statistical Analysis Plan (SAP) - Interim analysis
  • Template | Statistical Analysis Plan (SAP) - Final analysis
  • Template | Statistical Analysis Plan (SAP) - Interim analysis
  • Template | Observational Studies Analysis Plan

Please review  CEBU's Researcher Resources page

Training

External Resources

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Research oversight

CRDO Resources

Trial Governance

Data Safety Monitoring

External Resources

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Budgeting and contracts

Research projects must be appropriately costed to ensure the department and the instituted are protected.

CRDO Resources

Melbourne Children’s Resources

You can seek personalised support from the  MCRI Grants Office and Legal Office. You can find their contact information, resources, advice and templates on the MCRI intranet. 

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