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.
This Launching Pad provides guidance, procedures, and templates to help you conduct your research involving participants efficiently while meeting these standards. These resources has been developed and compiled by the Clinical Research Development Office (CRDO) and Murdoch Clinical Trials Centre (MCTC) and are based on The Royal Children's Hospital and Murdoch Children's Campus policies, and external National/International guidance.
We hope they will support researchers to conduct high-quality research including clinical trials and observational research, and we ask that you please acknowledge the Murdoch Children's when using these resources in your research.
Resources to support qualitative research may be found on the Qualitative Research page.
For general guidance on conducting research across the Royal Children's Hospital / Murdoch Children's campus, see the Melbourne Children’s Research Hub.
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 lay person when explaining your idea.
Clinical Research Development Office (CRDO) resources
Guidance | Setting up a research budget (PDF)
Template | Clinical Research Budget (downloadable excel) - Workshop | Budgeting for research workshop (internal staff only)
Melbourne Children’s resources
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Murdoch Children's Preparatory thinking for a new grant application worksheet (internal staff only)
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Murdoch Children's Grants office - tips and templates (internal staff only)
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 show email address .
Clinical Research Development Office (CRDO) resources
Guidance | Developing, amending and complying with research protocols (PDF)
Clinical 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.
- Clinical 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.
- Observational 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.
- Clinical 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 show email address .
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
- Translation Toolkit (downloadable word doc)
- APRN Research Measure Library
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
- Library training at The Royal Children's Hospital | Literature searching, referencing and more
- CEBU training | Foundations of Health Research Methods
- CEBU training | Observational studies: Modern concepts & analytic methods
Other Resources
Research oversight
Clinical Research Development Office (CRDO) resources
Trial Governance
- Template | Trial Steering Committee Charter (downloadable word doc)
Data Safety Monitoring Boards (DSMB)
- Guidance | DSMB (PDF)
- Template | DSMB Charter (downloadable word doc)
- Template | DSMB meeting agenda (downloadable word doc)
- Template | Report to the DSMB (downloadable word doc)
Other resources
Budgeting and contracts
Research projects must be appropriately costed to ensure the department and the instituted are protected.
Clinical Research Development Office (CRDO) resources
- Guidance | Budgeting in research (PDF)
- Template | Clinical Research Budget (downloadable excel document)
- Workshop | Budgeting for a research workshop, Murdoch Children's (Internal staff only)
Melbourne Children’s resources
- Template | Budget for grant proposals, Murdoch Children's (Internal staff only)
- Governance and regulatory documents, Research Governance and Ethics - The Royal Children's Hospital
- Process map | Clinical Trial Contracts, Indemnities and Clinical Trial Notification (CTN) (PDF)
Visit the Murdoch Children's Grants Office and Legal Office (internal) for personalised support, contact information, resources, advice and templates.
Murdoch Children's sponsorship
Investigator-initiated clinical trials (i.e. initiated and organised by an individual rather than an external collaborative network, company or organisation) need to request the Murdoch Children's act as the legal representative for a trial, acting as the Sponsor.
Melbourne Children’s resources
Clinical trial registration and Clinical Trial Notification (CTN)
Clinical Research Development Office (CRDO) resources
Clinical trials that use an unapproved therapeutic good or use an approved therapeutic outside the conditions of its registration must submit a CTN notifying the TGA.
Trials require evidence of CTN submission prior to receiving Royal Children's Hospital (RCH) governance approval. We recommend you begin your CTN draft when you submit your study for ethics approval.
Please submit the Clinical Trials Notification request form if you need to organise a CTN. You should anticipate a minimum of 2-3 weeks for your CTN to be fully processed.
A CTN is required as a part of your Governance Submission regulatory documents. Regulatory documents refer to those necessary for reporting the conduct of drug and device trials to the government. For more information, see below.
Ethics and governance
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 are subject to satisfactory progress reporting and other requirements.
Melbourne Children’s resources
The Royal Children's Hospital Governance and regulatory documents, Research Ethics and Governance (REG) page provides comprehensive information on all aspects. For a visual summary, refer to the process maps shown below:
- Process map | Ethics and Governance - Stand Alone Site (PDF)
- Process map | Ethics and Governance - Lead and Accepting Sites (PDF)
Clinical Research Development Office (CRDO) workshops
Other resources
Study record management and essential documents
Clinical Research Development Office (CRDO) resources
Filing guidance
Trial Master File (TMF)
The collection of essential documents used by the Sponsor-Investigator/CPI for the management of the trial.
- Guidance | Trial Master File (TMF) filing (PDF)
- Trial Master File (TMF) Table of Contents (downloadable word doc)
- Trial Master File (TMF) paper binder section dividers (downloadable word doc)
Site Information File (SIF)
A subsection of the TMF contains duplicates of site-specific essential documents required for the management of the trial. These are also held in the Investigator Site File (ISF) for and by the Principal Investigator.
- Guidance | Site Information File (SIF) filing (PDF)
- Site Information File (SIF) Table of Contents (downloadable word doc)
- Site Information File (SIF) paper binder section dividers (downloadable word doc)
Investigator Site File (ISF)
The collection of essential documents used by the Principal Investigator for the management of the trial at the site.
- Guidance | Investigator Site File (ISF) filing (PDF)
- Investigator Site File (ISF) Table of Contents (downloadable word doc)
- Investigator Site File (ISF) paper binder section dividers (downloadable word doc)
The filing structures detailed in these guidance documents are available on request. Please email
show email address
to request these.
Please note: Storing the TMF, SIF and/or ISF on a computer drive is not GDPR or GCP compliant, and is not appropriate for Clinical Trials.
Florence eBinders
CRDO recommends using Florence eBinders, a fully validated FDA 21 CFR Part 11, HIPAA, ICH-GCP and GDPR-compliant service. The system has audit trails, is backed up 3 times a day, and is a validated and compliance-tested program.
Florence eBinders also offers a range of project management tools. The electronic format allows for forwarding correspondence directly into eBinders via email, eSignatures, redacting/de-identifying and annotating source documents, and setting expiration dates on documents to improve efficiency and reduce duplication. Customisable Roles and Permissions allow for greater oversite of document management.
- Florence eBinders
- Compare Florence eBinders to other document solutions (PDF)
- Workflow | eLog Management and Troublehshooting (PDF)
- Workflow | Emails in Florence (PDF)
Other filing resources
- Standard Operating Procedure (SOP) |Document Management and Version Control (PDF)
- Guidance | Electronic File Naming Conventions (PDF)
- Guidance | Copying and Certifying Essential Documents (PDF)
- Template | Note to file (downloadable word doc)
All international clinical trials sponsored by MCRI must use Florence eBinders to ensure that they are fully 21 CFR Part 11 and GDPR compliant.
Melbourne Children’s resources
- Murdoch Children's Archiving Service Desk (Internal staff only)
- Policy | The Royal Children's Hospital | Research Documents and Records
Privacy and data protection
Clinical Research Development Office (CRDO) resources
- Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context: A Guideline for Researchers (PDF)
- Cheatsheet for Researchers | General Data Protection Regulation (GDPR) (PDF)
- Checklist | Data protection (downloadable word doc)
External resources
Study management
The templates below provide an abbreviated guide to the tasks involved in setting up, conducting and completing a study.
Clinical Research Development Office (CRDO) resources
Standard Operating Procedure (SOP)
- SOP | Study start-up for clinical trials (PDF)
- Checklist | Study feasibility (downloadable word doc)
- Timeline | Study Tasks (downloadable excel document)
- Template | Study start-up checklist (downloadable word doc)
- Template | Site Activation Letter (downloadable word doc)
- SOP | Site Initiation (PDF)
- Summary | Site Initiation (PDF)
- Template | Site Initiating Booking Letter (downloadable word doc)
- Template | Site Initiation Agenda (downloadable word doc)
- Template | Site Initiation Attendance Log (downloadable word doc)
- Template | Essential Document Request Letter (downloadable word doc)
- Template | Site Initiation Follow-Up Letter (downloadable word doc)
- Template | Site Initiation Follow-Up Report (downloadable word doc)
- SOP | Regulatory Green Light Approval for Clinical Trial Site Activation (PDF)
- Template | Regulatory Green Light Approval form (downloadable word doc)
- SOP|SOP Creation, implementation and revision (PDF)
- Checklist | Study closure (downloadable word doc)
- Workshop | Good Clinical Practice (GCP) in Research
Melbourne Children's resources
- Research Integrity (internal staff only)
Other resources
- Australian Code for the Responsible Conduct of Research and its supporting guidance documents
- National/International Guidance and Policies
Study team management
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 they delegate to study team members. Keeping records of the team and their activities is essential for evaluating the conduct of the study.
Clinical Research Development Office (CRDO) resources
- Documenting Trial Personnel Responsibilities, Qualifications and Training for Investigator-Initiated Trials (IITs) (downloadable word doc)
- Template | Study team training log (downloadable word doc)
- Guidance & template | Delegation & Signature Log (downloadable word doc)
- Template | Investigator short CV (Clinical Trials) (downloadable word doc)
- Template | Wet Ink Signature Log (downloadable word doc)
Melbourne Children’s resources
- Policy | Murdoch Children's Human Resources (internal staff only)
Recruitment and informed consent
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.
Melbourne Children’s Resources
Clinical Epidemiology and Biostatistics Unit (CEBU) resources
The CEBU page includes the following resources:
- Standard Operating Procedure (SOP) | Generating Randomisation Schedules
- Standard Operating Procedure (SOP) | Sample Size Estimation
- Form | Sample Size Estimation
The Royal Children's Hospital (RCH) resources
The RCH Research Ethics and Governance (REG) page provides comprehensive information and templates including:
- Recommended procedures for different methods of consent
- Plain Language guides
- Consent form templates
More information:
- Plain language style guide, The Royal Children's Hospital
- Policy | Informed Consent in Research, The Royal Children's Hospital
Clinical Research Development Office (CRDO) resources
- Guidance | Recruitment, Screening & Enrolment (downloadable word doc)
- Template | Pre-Screening Log (downloadable word doc)
- Template | Consent Screening & Enrolment Log (downloadable word doc)
Other resources
Data collection and management
Good data management is a foundation of good research. If data are properly organised, preserved and well documented, and their accuracy, validity and integrity are controlled at all times, the result is high-quality data, efficient research, outputs based on solid evidence and the saving of time and resources.
- Murdoch Children's Policy | Data Protection Policy & Procedure (MCRI5001 - Internal staff only)
Melbourne Children’s Resources
Clinical Epidemiology & Biostatistics (CEBU) provides advice and consultation, research methods and software training, for example:
- Training | Research Data Essentials
- Training | My Data Rules
- Training | Stata short courses
- Training | REDCap short courses
Clinical Epidemiology and Biostatistics Unit (CEBU) resources
The CEBU Researcher page includes the following resources:
- Data Management Plan Template
- CRF Review Checklist
- REDCap guidance
Clinical Research Development Office (CRDO) resources
- Guidance & template | Source Document Plan Guidance and Template (downloadable word doc)
- Guidance & template | Data collection for research: source documents and the Case Report Form (CRF) (PDF)
The Good Clinical Practice (GCP) course covers basic aspects of data collection and management.
Other resources
- National/International Guidance and Policies | Privacy and Guardianship
- FDA Guidance on electronic data (if running a trial with sites in the USA).
Biospecimen collection and management
All biospecimen 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 Murdoch Children's Biobanking Facility.
Clinical Research Development Office (CRDO) resources
Melbourne Children’s resources
The Murdoch Children's Biobanking Facility is part of the Melbourne Children's Bioresource Centre (MCBC) - contact at show email address .
Other resources
Radiation in research
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). You must complete the necessary forms required by the Research Ethics and Governance Office.
Melbourne Children’s resources
- Policy | Radiation Safety in Research, The Royal Children's Hospital (RCH)
- For the most up-to-date information, see About Medical Imaging at the RCH.
For guidance on how to seek approval from the Research Ethics and Governance (REG) office to use radiation in research, please visit Research Governance and Ethics, The Royal Children's Hospital.
Other resources
For national (ARPANSA) codes of practice and state (Victorian) laws and regulations, refer to the National/International Guidance and Policies page.
In this section
Risk management and safety reporting
Clinical Research Development Office (CRDO) resources
Risk management
- Risk assessment and management tool (PDF)
- Standard Operating Procedure (SOP) creation, implementation and revision (downloadable word doc)
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- Template | Standard Operating Procedure (SOP) / Guidance Document (downloadable word doc)
- Continuous improvement: a corrective and preventive action (CAPA) plan (downloadable word doc)
- Template | Continuous improvement: a corrective and preventive action (CAPA) plan (downloadable word doc)
- Template | CAPA Tracking Log (downloadable word doc)
Safety reporting
- SOP | Safety Monitoring and Reporting Procedure for MCRI-sponsored investigator-Initiated Trials of Medicines/Medical Devices (PDF)
- Template | Expedited Safety Report Form (downloadable word doc)
- Template | Clinical Review of Safety Events form (downloadable word doc)
- Process map | Site PI Safety Reporting (IIT) (PDF)
- Process map | Sponsor Safety Reporting (IIT) (PDF)
- Timeline I Safety Reporting Timelines for IMPs (PDF)
- Timeline I Safety Reporting Timelines for IMDs (PDF)
Non-compliance and serious breach reporting
- SOP | MCRI Sponsor-Investigator Management of non-compliance: Protocol Deviations and Serious Breaches (PDF)
- SOP | MCRI / RCH Site Principal Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches (PDF)
- Template | Non-compliance report form (downloadable word doc)
- Template | Third Party Suspected Breach report form (downloadable word doc)
- Template | Non-compliance review form (downloadable word doc)
- Template | Site non-compliance log (downloadable word doc)
- Template | Central non-compliance log (downloadable word doc)
- Quick reference | Table of Non-compliance reporting timelines (PDF)
Melbourne Children’s resources
Other resources
Study monitoring and auditing
Clinical Research Development Office (CRDO) resources
- Standard Operating Procedure (SOP) Monitoring Visit Activities (PDF)
- Template | Clinical Monitoring Plan (downloadable word doc)
- Template | Monitoring Visit Report (downloadable word doc)
- Template | Participant Monitoring (downloadable word doc)
- Workshop | Trial Monitoring
- Fact Sheet | Monitoring using Microsoft Teams (PDF)
- Fact Sheet | Monitoring using Parkville Connect (PDF)
Other resources
In this section
Data Sharing and Access
The Murdoch Children’s aims to facilitate the transfer of knowledge among researchers. The objective of data sharing is to maximise the value of a dataset by promoting further opportunities for research.
The following documents have been prepared to set out the process for the release of data from the Murdoch Children's Investigator-Initiated Trials (IIT).
The aim is to make sure data transfers are carefully considered and documented and to enable the Murdoch Children's to comply with its data access responsibilities and legal obligations.
The Standard Operating Procedure (SOP) is applicable to all datasets derived from research activities sponsored by the Murdoch Children's, including single-site research, collaborative multi-centre research, and investigator-initiated clinical trials.
Clinical Research Development Office (CRDO) resources
Data analysis and publication
Melbourne Children's resources
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.
Clinical Epidemiology and Biostatistics Unit (CEBU) resources
The CEBU provides advice and consultation and research methods and software training on:
- Introduction to Biostatistics
- Research Data Essentials
- My Data Rules
- Stata short courses
- REDCap short courses
CEBU resources include:
- SOP | Statistical Analysis Plan (SAP) - Final analysis
- Template | Statistical Analysis Plan (SAP) - Final analysis
- SOP | Statistical Analysis Plan (SAP) - Interim analysis
- Template | Statistical Analysis Plan (SAP) - Interim analysis
- Template| Observational Studies Analysis Plan
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