Post approval project management
Post approval project management including amendments, progress reports, safety reports, breaches, audits and archiving.
Alfred Health has a responsibility to monitor research in accordance with the Australian Code for the Responsible Conduct of Research and the National Statement on Ethics Conduct in Human Research (2007).
Monitoring occurs through:
- Progress reporting
- Review of adverse events
- Review of deviations from the proposed research plan
- Review of reports from researchers and safety monitoring boards
- Key performance indicators
- Feedback from participants
Researchers must monitor their research in accordance with the National Statement and complete progress reports and report adverse events and unexpected outcomes promptly to the Office of Ethics & Research Governance.
Australian Code for the Responsible Conduct of Research
The Australian Code for the Responsible Conduct of Research (the Code) guides institutions and researchers in responsible research practices and promotes research integrity. It assists institutions in developing their own employee codes of conduct and procedures for the investigation of allegations of research misconduct by providing a comprehensive framework of acceptable academic standards.
National Statement on Ethical Conduct in Human Research (2007)
The National Statement on Ethical Conduct in Human Research (2007) (National Statement (2007)) consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992. The National Statement is subject to rolling review.