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
Statistical support can be provided by:
Statistical support for clinical trial planning - A Victorian Comprehensive Cancer Centre (VCCC) biostatistician is available to provide statistical coaching during the planning phase of clinical trials. Coaching sessions will apply a statistical lens to clinical trial design and protocol development, to provide guidance and advice. Please note: analysis and calculations will not be provided in these consultations.
To inquire about coaching sessions, contact Anneke Grobler at: firstname.lastname@example.org
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