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Launching Pad

Launching Pad

What is this page for?

All researchers are required to conduct research in a manner that meets the standards of the Melbourne Children’s campus and National guidance.

The Launching Pad provides guidance, procedures, and templates to help you conduct your trials efficiently while meeting these standards.

While these resources have been tailed for the Melbourne Children's campus, it is open for all researchers to use. If you are external to the Melbourne Children's, please ensure you credit both the MCRI and CRDO when using our tools.

Use our contents to find what you need, or CTRL+F to search a word or phrase within the page.

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DEVELOPMENT

PROCEDURES

APPROVALS

QUALITY ASSURANCE

MANAGEMENT

SHARE FINDINGS

  

For a full list of CRDO Documents, go through the CRDO Resource List page.

For campus policies on multiple aspects of research conduct and misconduct refer to all sections on the Campus policies page

Refer also to the National/International guidance page for external guidance on research conduct and misconduct (all sections but especially 'Ethics and research conduct'). 

For campus research support (REG/CRDO/MCTC) refer to Campus research support. 


Development

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.info@mcri.edu.au

CRDO Resources

1. Clinical Trial (drug/device intervention) annotated template (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.

2. Clinical Trial (intervention is not drug/device) annotated template (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.

3. Observational Studies annotated template (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.

4. Clinical Audits / Quality Assurance 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.

5. 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

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

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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Approvals

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

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Clinical trial registration and CTN

CRDO Resources

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

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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:

CRDO Resources

External Resources

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Management

Study record management and essential documents

CRDO Resources

Filing Guidance

If you are using Windows for filing, a zip folder of the filing structures detailed in these guidance documents is available on request. Please email crdo@mcri.edu.au to request these.

Other Filing Resources

Florence eBinders

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

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Privacy and Data Protection

CRDO Resources

External Resources

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Study Management

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

CRDO Resources

External Resources

CRDO’s National/International guidance page collates relevant national and international policies and guidance.

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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

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Procedures

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

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

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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

 

CRDO Resources

The CRDO GCP course also covers some basic aspects of data collection and management.

External Resources

 

If running a trial with sites in the USA, please review the FDA Guidance on electronic data.

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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

Melbourne Children’s Resources

The MCRI Biobanking Facility forms part of the Melbourne Children's Bioresource Centre (MCBC) - contact via biobanking@mcri.edu.au

CAMPUS POLICIES| Biospecimen Collection and Management

External Resources

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

Melbourne Children’s Resources

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

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Quality Assurance

Risk management and safety reporting

CRDO Resources

Risk Management

Safety Reporting

Melbourne Children’s Resources

External Resources

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Study monitoring and auditing

CRDO Resources

External Resources

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Sharing Findings

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

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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

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