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
- GUIDANCE | Setting up a research budget
- TEMPLATE | Clinical Research Budget
- WORKSHOP | Budgeting for research workshop (internal only)
Melbourne Children’s Resources
-
Worksheet | Preparatory thinking for a new grant application (internal only)
-
Grants office Tips and Templates (internal 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 of the templates below is best for your study, please email show email address
CRDO Resources
Guidance | Developing, amending and complying with research protocols- Clinical Trial (drug/device intervention) annotated template (last updated 29 November 2019)
- Clinical Trial (intervention is not drug/device) annotated template (last updated 2 September 2019)
- Observational Studies annotated template (last updated 4 June 2019)
- Clinical Audits / Quality Assurance protocol template
- Qualitative Research
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.
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.
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.
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.
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 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
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
- CEBU WORKSHOP | Foundations of Health Research Methods
- CEBU WORKSHOP | Observational studies: Modern concepts & analytic methods
External Resources
Research oversight
CRDO Resources
Trial Governance
Data Safety Monitoring
- Guidance | DSMB
- Template | DSMB Charter
- Template | DSMB meeting agenda
- Template | Report to the DSMB
External Resources
Budgeting and contracts
Research projects must be appropriately costed to ensure the department and the instituted are protected.
CRDO Resources
- GUIDANCE | Budgeting in research
- TEMPLATE | Clinical Research Budget
- WORKSHOP | Budgeting for research workshop (Internal only)
Melbourne Children’s Resources
- TEMPLATE | Budget for grant proposals (Internal only)
- Research agreements & regulatory documents - An overview (RCH REG)
- Research agreements & regulatory documents - Process maps
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.
In this section
MCRI 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.
Melbourne Children’s Resources
Clinical trial registration and CTN
CRDO Resources
Clinical trials which 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 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 refers to those necessary for reporting the conduct of drug and device trials to the government. For more information, see the REG office's Research agreements & regulatory documents - An overview
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 is subject to satisfactory progress reporting and other requirements – refer to the RCH Research Ethics Governance website for details.
Melbourne Children’s Resources
The RCH Research Ethics Governance web pages provide comprehensive information on all aspects. For a visual summary, refer to the process maps shown below:
- Process map Ethics and Governance - Stand Alone Site
- Process map Ethics and Governance - Lead and Accepting Sites
CRDO Resources
External Resources
Study record management and essential documents
CRDO Resources
Filing Guidance
GUIDANCE| Filing definitions and principles
Trial Master File (TMF): The collection of essential documents used by the Sponsor-Investigator/CPI for the management of the trial.
Site Information File (SIF): A subsection of the TMF which contains duplicates of site-specific essential documents required for management of the trial. These are also held in the Investigator Site File (ISF) for and by the Principal Investigator.
Investigator Site File (ISF): The collection of essential documents used by the Principal Investigator for the management of the trial at the site.
The filing structures detailed in these guidance documents is 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 therefore not appropriate for Clinical Trials.
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.
Compare Florence eBinders to other document solutions
Other Filing Resources
- GUIDANCE | Electronic File Naming Conventions
- GUIDANCE | Copying and Certifying Essential Documents
- TEMPLATE | Note to file
All international clinical trials sponsored by MCRI must use Florence eBinders to ensure that they are fully 21 CFR Part 11 and GDPR compliant.
Please submit the eBinders request form to sign your trial up to Florence.
Melbourne Children’s Resources
Privacy and Data Protection
CRDO Resources
- Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context: A Guideline for Researchers
- GDPR Cheat Sheet for Researchers
- CHECKLIST | Data Protection Checklist
External Resources
Study Management
The template below provides an abbreviated guide to the tasks involved in setting up, conducting and completing a study.
CRDO Resources
- SOP | Study start up for clinical trials
- CHECKLIST | Study feasibility
- TIMELINE | Study Tasks (a template project timeline of major tasks from start to finish
- TEMPLATE | Study start up checklist
- TEMPLATE | Site Activation Letter
- SOP | Site Initiation
- Summary | Site Initiation
- SOP | Regulatory Green Light Approval for Clinical Trial Site Activation
Melbourne Children's Resources
- Research Integrity (MCRI intranet)
External Resources
CRDO’s National/International guidance page collates relevant national and international policies and guidance.
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 he/she delegates to study team members. Keeping records of the team and their activities is essential for evaluating the conduct of the study.
CRDO Resources
Melbourne Children’s Resources
MCRI POLICY | Human ResourcesRecruitment 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
For CEBU resources including
- SOP | Generating Randomisation Schedules
- SOP | Sample Size estimation
- Form | Sample Size estimation
Please review CEBU's Researcher Resources page
The RCH Research Ethics Governance
web pages provide comprehensive information and templates including:
- Recommended procedures for different methods of consent
- Plain Language guides
- Consent form templates
You should also review
CRDO Resources
External Resources
The Guardianship and Administration Act
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 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
Melbourne Children’s Resources
CEBU provides advice and consultation, as well as training covering
- WORKSHOP | Research Data Essentials
- WORKSHOP | My Data Rules
- WORKSHOP | Stata short courses
- WORKSHOP | REDCap short courses
For CEBU Resources including
- Data Management Plan Template
- CRF Review Checklist
- REDCap guidance
Please review CEBU's Researcher Resources page
MCRI POLICY | Data Protection Policy & Procedure (MCRI5001)CRDO Resources
- TEMPLATE + GUIDANCE| Source Document Plan Guidance and Template
- GUIDANCE + TEMPLATE | Data collection for research: source documents and the Case Report Form (CRF)
The CRDO GCP course also covers some basic aspects of data collection and management.
External Resources
NATIONAL POLICY | Privacy and GuardianshipIf running a trial with sites in the USA, please review the FDA Guidance on electronic data.
Biospecimen collection and management
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).
CRDO Resources
SOP | Sample collection and handlingMelbourne Children’s Resources
The MCRI Biobanking Facility forms part of the Melbourne Children's Bioresource Centre (MCBC) - contact via show email address
CAMPUS POLICIES| Biospecimen Collection and Management
External Resources
NATIONAL POLICIES | Biospecimen Collection and ManagementRadiation 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) and complete the necessary forms required by the Research Ethics and Governance Office.
Melbourne Children’s Resources
- RCH POLICY | Radiation Safety in Research
-
For the most up-to-date information, see the RCH page for Medical Imaging.
For guidance on how to seek approval from the Office of Research Ethics and Governance (REG) to use radiation in research, please visit the REG website.
External Resources
For national (ARPANSA) codes of practice and state (Victorian) law and regulations, refer to the National/International guidance page
In this section
Risk management and safety reporting
CRDO Resources
Risk Management
- Risk assessment and management tool
- SOP creation, implementation and revision
- Continuous improvement: a corrective and preventive action (CAPA) plan
Safety Reporting
Non-compliance and Serious Breach reporting
- SOP | MCRI Sponsor-Investigator Management of non-compliance: Protocol Deviations and Serious Breaches
- SOP | MCRI / RCH Site Principal Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches
Melbourne Children’s Resources
External Resources
NATIONAL POLICIES | Clinical trials, safety reporting and oversight of researchStudy monitoring and auditing
CRDO Resources
- SOP Monitoring Visit Activities
- WORKSHOP | Trial Monitoring
- Fact Sheet| Monitoring using Microsoft Teams
- Fact Sheet| Monitoring using Parkville Connect
External Resources
NHMRC GUIDANCE | Risk-based Management and Monitoring of Clinical TrialsIn this section
Data Sharing and Access
Murdoch Children’s Research Institute (MCRI) 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. To that end, following documents have been prepared to set out the process for the release of data from MCRI Investigator-Initiated Trials (IIT).
The aim is to make sure data transfers are carefully considered and documented, and to enable MCRI to comply with its data access responsibilities and legal obligations. The SOP is applicable to all datasets derived from research activities sponsored by the MCRI, including single site research, collaborative multi-centre research, and investigator-initiated clinical trials.
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.
CEBU provides advice and consultation, as well as training covering
- WORKSHOP | Introduction to Biostatistics
- WORKSHOP | Research Data Essentials
- WORKSHOP | My Data Rules
- WORKSHOP | Stata short courses
- WORKSHOP | REDCap short courses
For CEBU resources including
- 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
Please review CEBU's Researcher Resources page
MCRI POLICY | Publication