Post approval project management

Post approval project management including amendments, progress reports, safety reports, breaches, audits and archiving.

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Monitoring research

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 (2023).

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
  • Review of audit reports
  • 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.

NMHRC resources

Australian Code for the Responsible Conduct of Research
The Australian Code for the Responsible Conduct of Research (the Code) provides institutions and researchers with the principles and responsibilities that underpin the conduct of research.
National Statement on Ethical Conduct in Human Research (2023)
The National Statement on Ethical Conduct in Human Research (2023) consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992.