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Launching Pad

Clinical research resources and training at the Melbourne Children's

Research conduct and misconduct

Data and Safety

Consent

Social media

Research documents and records

* Both guidelines detail what needs to be included - and why. Below, there are templates such as delegation and recruitment logs to use in conjunction with this guideline. For those who prefer to file electronically (or have a mix of paper and electronic) let us know. We have an electronic file structure we can email you that is identical to the paper version.

Budgeting

Radiation in research

Publications

Human tissue

Overseas research

Conflicts of interest

  • Conflict of Interest policy and procedure (MCRI1015)

  • Researchers should address consideration of financial interest in both the HREA (for each investigator section & the duality of interest section) and the application cover letter. 

Adverse (Safety) Event Management 

Ethics and research conduct 

Good Clinical Practice (GCP)

Electronic records

Privacy and guardianship

Human tissue and genes

Therapeutic goods and safety reporting

Radiation in research

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.

Tools and templatesTrainingOther SupportCampus guidelines, policies and proceduresNational and international guidelines

Government funding bodies and philanthropic trusts and foundations award grants and fellowships/scholarships following a rigorous selection process based on scientific quality and significance, and applicant track record. With an overall reduction in the funding pool, an increasing number of applications and increasing budget costs for proposed projects, a strategic approach to writing funding applications is needed.

Tools and templatesTrainingOther SupportCampus guidelines, policies and proceduresNational and international guidelines
 

It is essential that studies are designed and conducted to national, state and institutional guidance to assure ongoing protection of research participants' rights, scientific integrity of the research and the generation of credible data. The processes involved in assuring appropriate study design and conduct are referred to as oversight.

As of January 2018 we are awaiting the release of a number of new guidance documents and templates from NHMRC. 

Tools and templatesTrainingOther SupportCampus guidelines, policies and proceduresNational and international guidelines
 

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

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Research projects must be appropriately costed to ensure the department and the instituted are protected. Regulatory documents refers to those necessary for reporting the conduct of drug and device trials to the government.

Tools and templatesTrainingOther SupportCampus guidelines, policies and proceduresNational and international guidelines

The following hyperlinks will take you to the relevant page (but not document) on the CRDO, MCRI or REG page

All research conducted on or by the Melbourne Children's campus must be approved by a Human Research Ethics Committee (HREC) and before it can commence. Projects are also reviewed by the 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.   

Tools and templatesTrainingOther SupportCampus guidelines, policies and proceduresNational and international guidelines

For all forms for REG applications visit the REG website.

Research conduct 

Available on the RCH intranet

Available on the MCRI intranet (see 'Research' section) 

Research misconduct

All research

Clinical Trials

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.

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Templates for PICF and recruitment documents - see RCH Research Ethics Governance site

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

Tools and templatesTrainingOther SupportCampus guidelines, policies and proceduresNational and international guidelines

CEBU provides advice and consultation as well as a range of training courses (research methods & use of REDCap)


 
 

Data usage 

Data protection

All research

Clinical trials only

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 the Biobanking Advisory Committee (BAG) can assist.

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

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For all forms for REG applications visit the REG website 

An adverse event (AE) is defined as any untoward medical occurrence in a study participant, regardless of whether or not it is thought to be related to study procedures or to a study intervention (e.g. an experimental drug or device; a behavioural intervention; a procedural intervention). All adverse events that occur in a study have to be logged, and some reported to an ethics committee or institutional committee.

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The REG website provides links to the guidance document and process map (a flowchart) for safety reporting.

Note also that for clinical trials using a DSMB to oversee the trial you will find links to the CRDO guidance documents and templates.

The CRDO GCP course also covers safety monitoring and reporting in more limited detail.

The REG website provides links to the guidance document and process map (a flowchart) for safety reporting.

Note also that for clinical trials using a DSMB to oversee the trial you will find links to the CRDO guidance documents and templates.

Tools and templatesTrainingOther SupportCampus guidelines, policies and proceduresNational and international guidelines

The CRDO Investigator Site File (Study Binder) guidance/template provides full details of what must be maintained – you will find many useful associated forms & templates here as well (e.g. Staff signature & delegation log, study start-up checklist, Screening and enrolment logs, “Note to File” template etc).

For multi-site research, there is also guidance as to what must be retained by the coordinating site for its participating sites.

The CRDO GCP course covers elements of document management

Those conducting a study must be appropriately trained and qualified to perform the research procedures they're delegated. Keeping records of the team and their activities is essential for evaluating the conduct of the study.

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Good quality data analysis will translate raw data into meaningful results which can be publish in peer review journals. In order to change practice through research it is essential to have high quality data. 

Tools and templatesTrainingOther SupportCampus guidelines, policies and proceduresNational and international guidelines
 
  • CEBU provides advice and consultation as well as a range of training courses (research methods & use of STATA)