The Office for Research provides important resources to assist investigators and research personnel with conducting research.
- Melbourne Health protocol template
- SPIRIT 2013 Statement: This provides recommendations for a minimum set of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol.
- Consort Statement: Provides standards for reporting trials that should be considered in development of trial protocols.
- MH statistical review process and MH statistical review proforma
- Peer review process and Peer Review Proforma
The MH Office for Research has made arrangements for the University of Melbourne - Melbourne Clinical and Translational Sciences (MCATS) research platform to provide statistical support for MH researchers.
MCATS can provide collaborative Biostatistics and Health Economics research support, research and grant development, analysis and publication. For more information or to contact MCATs visit the MCATS website.
Literature Review support
Comprehensive / systematic literature review support can be provided by:
- Details of training requirements and sessions, including Good Clinical Practice training at Melbourne Health are listed on the Research Education and Training page.
Australian Regulatory Authorities
- Therapeutic Goods Administration
- Note for guidance on good clinical practice
- National Health and Medical Research Council
- Medicines Australia
NHMRC Australian Health Ethics Committee (AHEC) Information for Human Research Ethics Committees
- National Statement on Ethical Conduct in Human Research (2007)
- Australian Code for the Responsible Conduct of Research
- Safety monitoring and reporting in clinical trials involving therapeutic goods (2016)
Risk-based Management and Monitoring of Clinical Trials involving Therapeutic Goods (2018) https://www.nhmrc.gov.au/about-us/publications/safety-monitoring-and-reporting-clinical-trials-involving-therapeutic-goods
Reporting of Serious Breached of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods (2018) https://www.nhmrc.gov.au/about-us/publications/safety-monitoring-and-reporting-clinical-trials-involving-therapeutic-goods
Data Safety Monitoring Boards (DSMBs) (2018) https://www.nhmrc.gov.au/about-us/publications/safety-monitoring-and-reporting-clinical-trials-involving-therapeutic-goods
Australian code for the care and use of animals for scientific purposes (the Code, 2013) https://www.nhmrc.gov.au/about-us/publications/australian-code-care-and-use-animals-scientific-purposes
Best practice methodology in the use of animals for scientific purposes (2017) https://www.nhmrc.gov.au/about-us/publications/best-practice-methodology-use-animals-scientific-purposes
- Human Ethical Issues
- Ethical Aspects of Human Genetic Testing
- Ethical Considerations in Quality Assurance and Evaluation Activities
Victorian Managed Insurance Authority
Other Human Ethics Resources
- Monash Bioethics Review
- World Medical Association, Declaration of Helsinki (1996)
- Canadian Institutes of Health: Responsible Conduct of Research