Research process resources: Development

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Grant writing and management

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.

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.

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

Clinical Research Development Office (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 template is best for your study, please email us at  .

Clinical Research Development Office (CRDO) resources

pdf Guidance | Developing, amending and complying with research protocols (PDF)
  1. docClinical Trial (drug/device intervention) annotated template (downloadable word doc) - last updated  29 November 2019

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.

  1. docClinical Trial (intervention is not drug/device) annotated template (downloadable word doc) - last updated  2 September 2019

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.

  1. docObservational Studies annotated template (downloadable word doc) - last updated  4 June 2019

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.

  1. docClinical Audits / Quality Assurance (downloadable word doc) - protocol template 

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.

Qualitative research 

There are currently no templates for qualitative research, however, for advice in developing your protocol/ethics application please contact our 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


Clinical Epidemiology and Biostatistics Unit (CEBU) resources

You can find the following resources on the CEBU page:

  • 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


Training


Other Resources

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Research oversight

Clinical Research Development Office (CRDO) resources

Trial Governance

Data Safety Monitoring Boards (DSMB)


Other resources

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Budgeting and contracts

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

Clinical Research Development Office (CRDO) resources


Melbourne Children’s resources

Visit the Murdoch Children's Grants Office and Legal Office (internal) for personalised support, contact information, resources, advice and templates.

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