Research process resources: Procedures
“Important note: All documents can be found on the METIS Database. You can search using the document code or key words in title.”
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
- 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.
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